[Federal Register Volume 68, Number 123 (Thursday, June 26, 2003)]
[Notices]
[Pages 38071-38083]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 03-16109]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0161]


Medical Devices; Reprocessed Single-Use Devices; Termination of 
Exemptions From Premarket Notification; Requirement for Submission of 
Validation Data

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is adding nonelectric 
biopsy forceps (classified in 21 CFR 876.1075, Gastroenterology-urology 
biopsy instrument) to the list of critical reprocessed single-use 
devices (SUDs) whose exemption from premarket notification requirements 
is being terminated and for which validation data, as specified under 
the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), is 
necessary in a premarket notification (510(k)). FDA is requiring 
submission of these data to ensure that reprocessed single-use 
nonelectric biopsy forceps are substantially equivalent to predicate 
devices, in accordance with MDUFMA.

DATES: These actions are effective June 26, 2003. Manufacturers of 
reprocessed

[[Page 38072]]

single-use biopsy forceps must submit 510(k)s for these devices by 
September 27, 2004, or their devices may no longer be marketed.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.fda.gov/dockets/ecomments. Comments should be identified with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Barbara A. Zimmerman, Center for 
Devices and Radiological Health (HFZ-410), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850.

SUPPLEMENTARY INFORMATION:

I. Background

    On October 26, 2002, MDUFMA (Public Law 107-250) amended the 
Federal Food, Drug, and Cosmetic Act (the act) by adding section 510(o) 
(21 U.S.C. 360(o)), which provided new regulatory requirements for 
reprocessed SUDs. According to this new provision, in order to ensure 
that reprocessed SUDs are substantially equivalent to predicate 
devices, 510(k)s for certain reprocessed SUDs identified by FDA must 
include validation data. These required validation data include 
cleaning and sterilization data, and functional performance data 
demonstrating that each SUD will remain substantially equivalent to its 
predicate device after the maximum number of times the device is 
reprocessed as intended by the person submitting the premarket 
notification.
    Before enactment of the new law, a manufacturer of a reprocessed 
SUD was required to obtain premarket approval or premarket clearance 
for the device, unless the device was exempt from premarket submission 
requirements. Under MDUFMA, some previously exempt reprocessed SUDs 
will no longer be exempt from premarket notification requirements. 
Manufacturers of these identified devices will need to submit 510(k)s 
that include validation data to be specified by FDA. Reprocessors of 
certain SUDs that currently have cleared 510(k)s also will need to 
submit the validation data specified by the agency.

A. Definitions

    Under section 302(d) of MDUFMA, a reprocessed SUD is defined as an
    ``* * * original device that has previously been used on a 
patient and has been subjected to additional processing and 
manufacturing for the purpose of an additional single use on a 
patient. The subsequent processing and manufacture of a reprocessed 
single-use device shall result in a device that is reprocessed 
within the meaning of this definition.''

B. Reprocessed SUDs Exempt From Premarket Notification

    Reprocessed SUDs are divided into three groups: (1) Critical, (2) 
semicritical, and (3) noncritical. The first two categories reflect 
definitions set forth in MDUFMA, and all three reflect a classification 
scheme recognized by the industry.\1\ These categories of devices are 
defined as follows:
---------------------------------------------------------------------------

    \1\ These are known in the industry as the Spaulding 
definitions, and are described in Spaulding, E. H., ``The Role of 
Chemical Disinfection in the Prevention of Nonsocomial Infections,'' 
P. S. Brachman and T. C. Eickof (ed), Proceedings of International 
Conference on Nonsocomial Infections, 1970, American Hospital 
Association, Chicago, IL 1971:254-274.
---------------------------------------------------------------------------

    1. A critical reprocessed SUD is intended to contact normally 
sterile tissue or body spaces during use.
    2. A semicritical reprocessed SUD is intended to contact intact 
mucous membranes and not penetrate normally sterile areas of the body.
    3. A noncritical reprocessed SUD is intended to make topical 
contact and not penetrate intact skin.

C. Requirements for Critical Reprocessed SUDs

    MDUFMA requires FDA to review the critical reprocessed SUDs that 
are currently exempt from premarket notification requirements and 
determine which of these devices require premarket notification to 
ensure their substantial equivalence to predicate devices. By April 26, 
2003, FDA was required to identify in a Federal Register notice those 
critical reprocessed SUDs whose exemption from premarket notification 
requirements will be terminated and for which FDA has determined that 
validation data, as specified under MDUFMA, is necessary in a 510(k). 
According to the new law, manufacturers of the devices whose exemption 
from premarket notification requirements is terminated must submit 
510(k)s that include validation data regarding cleaning, sterilization, 
and functional performance, in addition to all the other required 
elements of a 510(k) identified in 21 CFR 807.87, within 15 months of 
publication of the list or no longer market their devices.

II. FDA's Implementation of New Section 510(o) of the Act

    In the Federal Register of April 30, 2003 (68 FR 23139), FDA 
described the methodology and criteria it used to determine which 
previously exempt critical reprocessed SUDs are now subject to 510(k) 
submission requirements, including the submission of validation data. 
First, FDA described how it identified the types of SUDs being 
reprocessed and how the Spaulding definitions (see footnote 1) were 
used to categorize these devices as critical, semicritical, or 
noncritical. (This list, which was Attachment 1 to that Federal 
Register notice, is being reprinted as Attachment 1 to this notice.) 
Next, the agency described its use of the Risk Prioritization Scheme 
(RPS)\2\ that it used to evaluate the risk (high, moderate, or low) 
associated with an SUD based on: (1) Risk of infection and (2) risk of 
inadequate performance following reprocessing. FDA identified its final 
risk criterion as those reprocessed SUDs intended to come in contact 
with tissue at high risk of being infected with the causative agents of 
Creutzfeldt-Jakob Disease (CJD). (These are generally devices intended 
for use in neurosurgery and ophthalmology.)
---------------------------------------------------------------------------

    \2\ This scheme is described in the agency's February 2000 draft 
guidance document entitled ``Reprocessing and Reuse of Single-Use 
Devices: Review Prioritization Scheme.'' The document is available 
on the Internet at http://www.fda.gov/cdrh/reuse/1156.pdf.
---------------------------------------------------------------------------

    Using this methodology and criteria, the devices included in List I 
(``Critical Reprocessed Single-Use Devices Previously Exempt From 
Premarket Notification Requirements That Will Now Require 510(k)s With 
Validation Data'') of the April 30, 2003, Federal Register notice are 
those critical reprocessed SUDs that were either high risk according to 
the RPS or intended to come in contact with tissue at high risk of 
being infected with the causative agents of CJD.

III. Revisions to Attachment I, List I, and List II

A. Revisions to Attachment I (List of SUDs Known To Be Reprocessed or 
Considered for Reprocessing)

    FDA has re-evaluated the list of reprocessed SUDs with regard to 
the critical and semicritical device designations. In doing so, the 
agency has determined that all gastroenterology-urology biopsy 
instruments should be considered critical devices rather than 
semicritical devices because these devices are intended to break the 
mucous membrane and come in contact with sterile tissue when taking a 
biopsy. This includes biopsy forceps covers, biopsy instruments, biopsy 
needle sets, biopsy punches, mechanical biopsy instruments, and 
nonelectric biopsy

[[Page 38073]]

forceps (devices 42-47 in Attachment I). In addition, it was determined 
that rigid and nonrigid bronchoscope biopsy forceps and biliary 
sphincterotomes (devices 40, 41, and 55 in Attachment I) should also be 
considered critical devices rather than semicritical devices for the 
same reason as stated previously. These changes are reflected in a 
revised version of Attachment I included in this Federal Register 
notice.

B. Revisions to List I (Critical Reprocessed Single-Use Devices 
Previously Exempt From Premarket Notification Requirements That Will 
Now Require 510(k)s With Validation Data)

    FDA recategorized nine device types from semicritical to critical. 
One of these nine device types, nonelectric gastroenterology-urology 
biopsy forceps, was also considered high risk under the RPS. Therefore, 
nonelectric gastroenterology-urology biopsy forceps have been added to 
List I. Under MDUFMA, manufacturers of these biopsy forceps will be 
required to submit 510(k)s with validation data by (see DATES), which 
is 15 months following the publication of this revised list.
    In addition, FDA is taking this opportunity to clarify the date by 
which manufacturers of the other devices in List I are required to 
submit 510(k)s with validation data. The correct date is July 30, 2004, 
which is 15 months following the initial publication of the list (the 
April 30, 2003, Federal Register notice inadvertently identified two 
dates).

C. Revisions to List II (Reprocessed Single-Use Devices Subject to 
Premarket Notification Requirements That Will Now Require the 
Submission of Validation Data)

    The only change to List II is to clarify the date by which 510(k) 
submissions are required by MDUFMA to be supplemented with validation 
data. The correct date is January 30, 2004, which is 9 months following 
the initial publication of the list (as noted previously, the April 30, 
2003, Federal Register notice inadvertently identified two dates).

 List I.--Critical Reprocessed Single-Use Devices Previously Exempt From
 Premarket Notification Requirements That Will Now Require 510(k)s With
   Validation Data (to be submitted by July 30, 2004, unless otherwise
                                 noted).
------------------------------------------------------------------------
                              Product code  Product code   Product code
  21 CFR    Classification      for non-         for         name for
 section         name         reprocessed    reprocessed    reprocessed
                                 device        device         device
------------------------------------------------------------------------
872.3240   Dental bur        Diamond        NME           Dental diamond
                              coated                       coated bur
------------------------------------------------------------------------
872.4535   Dental diamond    DZP            NLD           Dental diamond
            instrument                                     instrument
------------------------------------------------------------------------
872.4730   Dental injection  DZM            NMW           Dental needle
            needle
------------------------------------------------------------------------
874.4140   Ear, nose, and    Microdebrider  NLY           ENT high speed
            throat (ENT)                                   microdebrider
            bur
------------------------------------------------------------------------
874.4140   Ear, nose, and    Diamond        NLZ           ENT diamond
            throat bur        coated                       coated bur
------------------------------------------------------------------------
874.4420   Ear, nose,        KAB, KBG, KCI  NLB           Laryngeal,
            throat manual                                  sinus,
            surgical                                       tracheal
            instrument                                     trocar
------------------------------------------------------------------------
876.1075\  Gastroenterology- FCL            NON           Nonelectric
 1\         urology biopsy                                 biopsy
            instrument                                     forceps
------------------------------------------------------------------------
878.4200   Introduction/     GCB            NMT           Catheter
            drainage                                       needle
            catheter and
            accessories
------------------------------------------------------------------------
878.4800   Manual surgical   MJG            NNA           Percutaneous
            instrument                                     biopsy device
------------------------------------------------------------------------
878.4800   Manual surgical   FHR            NMU           Gastro-urology
            instrument                                     needle
------------------------------------------------------------------------
878.4800   Manual surgical   DWO            NLK           Cardiovascular
            instrument for                                 biopsy needle
            general use
------------------------------------------------------------------------
878.4800   Manual surgical   GAA            NNC           Aspiration and
            instrument for                                 injection
            general use                                    needle
------------------------------------------------------------------------
882.4190   Forming/cutting   HBS            NMN           Forming/
            clip instrument                                cutting clip
                                                           instrument
------------------------------------------------------------------------
884.1730   Laparoscopic      HIF            NMI           Laparoscopic
            insufflator                                    insufflator
                                                           and
                                                           accessories
------------------------------------------------------------------------
884.4530   OB/GYN            HFB            NMG           Gynecological
            specialized                                    biopsy
            manual                                         forceps
            instrument
------------------------------------------------------------------------
886.4350   Manual            HNN            NLA           Ophthalmic
            ophthalmic                                     knife
            surgical
            instrument
------------------------------------------------------------------------
\1\ 510(k)s with validation data to be submitted by September 27, 2004.


[[Page 38074]]


      List II.--Reprocessed Single-Use Devices Subject to Premarket
    Notification Requirements That Will Now Require the Submission of
 Validation Data\1\ (Manufacturers who already have 510(k) clearance for
 these devices must submit validation data by January 30, 2004. Any new
  510(k) submitted after publication of the April 30 list will require
                            validation data.)
------------------------------------------------------------------------
                              Product code  Product code   Product code
  21 CFR    Classification      for non-         for         name for
 section         name         reprocessed    reprocessed    reprocessed
                                 device        device         device
------------------------------------------------------------------------
Unclassif  Oocyte            MHK            NMO           Oocyte
 ied        aspiration                                     aspiration
            needles                                        needles
------------------------------------------------------------------------
Unclassif  Percutaneous      LIT            NMM           Transluminal
 ied        transluminal                                   peripheral
            angioplasty                                    angioplasty
            catheter                                       catheter
------------------------------------------------------------------------
Unclassif  Ultrasonic        LFL            NLQ           Ultrasonic
 ied        surgical                                       scalpel
            instrument
------------------------------------------------------------------------
868.5150   Anesthesia        BSP            NNH           Anesthetic
            conduction                                     conduction
            needle                                         needle (with
                                                           or without
                                                           introducer)
------------------------------------------------------------------------
868.5150   Anesthesia        MIA            NMR           Short term
            conduction                                     spinal needle
            needle
------------------------------------------------------------------------
868.5730   Tracheal tube     BTR            NMA           Tracheal tube
                                                           (with or
                                                           without
                                                           connector)
------------------------------------------------------------------------
868.5905   Noncontinuous     BZD            NMC           Noncontinuous
            ventilator                                     ventilator
            (IPPB)                                         (respirator)
                                                           mask
------------------------------------------------------------------------
870.1200   Diagnostic        DQO            NLI           Angiography
            intravascular                                  catheter
            catheter
------------------------------------------------------------------------
870.1220   Electrode         DRF            NLH           Electrode
            recording                                      recording
            catheter                                       catheter
------------------------------------------------------------------------
870.1220   Electrode         MTD            NLG           Intracardiac
            recording                                      mapping
            catheter                                       catheter
------------------------------------------------------------------------
870.1230   Fiberoptic        DQE            NMB           Fiberoptic
            oximeter                                       oximeter
            catheter                                       catheter
------------------------------------------------------------------------
870.1280   Steerable         DRA            NKS           Steerable
            catheter                                       catheter
------------------------------------------------------------------------
870.1290   Steerable         DXX            NKR           Steerable
            catheter                                       catheter
            control system                                 control
                                                           system
------------------------------------------------------------------------
870.1330   Catheter guide    DQX            NKQ           Catheter guide
            wire                                           wire
------------------------------------------------------------------------
870.1390   Trocar            DRC            NMK           Cardiovascular
                                                           trocar
------------------------------------------------------------------------
870.1650   Angiographic      DXT            NKT           Angiographic
            injector and                                   injector and
            syringe                                        syringe
------------------------------------------------------------------------
870.1670   Syringe actuator  DQF            NKW           Injector for
            for injector                                   actuator
                                                           syringe
------------------------------------------------------------------------
870.2700   Oximeter          MUD            NMD           Tissue
                                                           saturation
                                                           oximeter
------------------------------------------------------------------------
870.2700   Oximeter          DQA            NLF           Oximeter
------------------------------------------------------------------------
870.3535   Intra-aortic      DSP            NKO           Intra-aortic
            balloon and                                    balloon and
            control system                                 control
                                                           system
------------------------------------------------------------------------
870.4450   Vascular clamp    DXC            NMF           Vascular clamp
------------------------------------------------------------------------
870.4885   External vein     DWQ            NLJ           External vein
            stripper                                       stripper
------------------------------------------------------------------------
872.5470   Orthodontic       DYW            NLC           Orthodontic
            plastic bracket                                plastic
                                                           bracket
------------------------------------------------------------------------
874.4680   Bronchoscope      BWH            NLE           Bronchoscope
            (flexible or                                   (nonrigid)
            rigid) and                                     biopsy
            accessories                                    forceps
------------------------------------------------------------------------
876.1075   Gastro-urology    FCG            NMX           G-U biopsy
            biopsy                                         needle and
            instrument                                     needle set
------------------------------------------------------------------------
876.1075   Gastroenterology- KNW            NLS           Biopsy
            urology biopsy                                 instrument
            instrument
------------------------------------------------------------------------
876.1500   Endoscope and     FBK, FHP       NMY           Endoscopic
            accessories                                    needle
------------------------------------------------------------------------
876.1500   Endoscope and     MPA            NKZ           Endoilluminato
            accessories                                    r
------------------------------------------------------------------------
876.1500   Endoscope and     GCJ            NLM           General and
            accessories                                    plastic
                                                           surgery
                                                           laparoscope
------------------------------------------------------------------------
876.1500   Endoscope and     FHO            NLX           Spring-loaded
            accessories                                    Pneumoperiton
                                                           eum Needle
------------------------------------------------------------------------

[[Page 38075]]

 
876.4300   Endoscopic        FAS            NLW           Active
            electrosurgical                                urological
            unit and                                       electrosurgic
            accessories                                    al electrode
------------------------------------------------------------------------
876.4300   Endoscopic        FEH            NLV           Flexible
            electrosurgical                                suction
            unit and                                       coagulator
            accessories                                    electrode
------------------------------------------------------------------------
876.4300   Endoscopic        KGE            NLU           Electric
            electrosurgical                                biopsy
            unit and                                       forceps
            accessories
------------------------------------------------------------------------
876.4300   Endoscopic        FDI            NLT           Flexible snare
            electrosurgical
            unit and
            accessories
------------------------------------------------------------------------
876.4300   Endoscopic        KNS            NLR           Endoscopic
            electrosurgical                                (with or
            unit and                                       without
            accessories                                    accessories)
                                                           Electrosurgic
                                                           al unit
------------------------------------------------------------------------
876.5010   Biliary catheter  FGE            NML           Biliary
            and accessories                                catheter
------------------------------------------------------------------------
876.5540   Blood access      LBW            NNF           Single needle
            device and                                     dialysis set
            accessories                                    (co-axial
                                                           flow)
------------------------------------------------------------------------
876.5540   Blood access      FIE            NNE           Fistula needle
            device and
            accessories
------------------------------------------------------------------------
876.5820   Hemodialysis      FIF            NNG           Single needle
            systems and                                    dialysis set
            accessories                                    with uni-
                                                           directional
                                                           pump
------------------------------------------------------------------------
878.4300   Implantable clip  FZP            NMJ           Implantable
                                                           clip
------------------------------------------------------------------------
878.4750   Implantable       GDW            NLL           Implantable
            staple                                         staple
------------------------------------------------------------------------
880.5570   Hypodermic        FMI            NKK           Hypodermic
            single lumen                                   single lumen
            needle                                         needle
------------------------------------------------------------------------
880.5860   Piston syringe    FMF            NKN           Piston syringe
------------------------------------------------------------------------
882.4300   Manual cranial    HBG            NLO           (Manual)
            drills, burrs,                                 drills,
            trephines, and                                 burrs,
            accessories                                    trephines,
                                                           and
                                                           accessories
------------------------------------------------------------------------
882.4305   Powered compound  HBF            NLP           (Powered,
            cranial drills,                                compound)
            burrs,                                         drills,
            trephines, and                                 burrs,
            accessories                                    trephines,
                                                           and
                                                           accessories
------------------------------------------------------------------------
882.4310   Powered simple    HBE            NLN           (Simple,
            cranial drills,                                powered)
            burrs,                                         drills,
            trephines, and                                 burrs,
            accessories                                    trephines,
                                                           and
                                                           accessories
------------------------------------------------------------------------
884.1720   Gynecologic       HET            NMH           Gynecologic
            laparoscope and                                laparoscope
            accessories                                    (and
                                                           accessories)
------------------------------------------------------------------------
884.6100   Assisted          MQE            NNB           Assisted
            reproduction                                   reproduction
            needles                                        needles
------------------------------------------------------------------------
886.4370   Keratome          HMY, HNO       NKY           Keratome blade
------------------------------------------------------------------------
886.4670   Phacofragmentati  HQC            NKX           Phacoemulsific
            on system                                      ation needle
------------------------------------------------------------------------
892.5730   Radionuclide      IWF            NMP           Isotope needle
            brachytherapy
            source
------------------------------------------------------------------------
\1\ Hemodialyzers have been excluded from this list because the reuse of
  hemodialyzers is addressed in FDA's ``Guidance for Hemodialyzer Reuse
  Labeling'' (final draft issued on October 6, 1995).

IV. Comments

    You may submit written or electronic comments on this notice to the 
Division of Dockets Management (see ADDRESSES). You may submit a single 
copy of an electronic comment to http://www.fda.gov/dockets/ecomments. 
You should submit two paper copies of any mailed comments but 
individuals may submit one paper copy. You should identify your comment 
with the docket number found in brackets in the heading of this 
document. You may see any comments FDA receives in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

[[Page 38076]]



         Attachment 1--List of SUDs Known To Be Reprocessed or Considered for Reprocessing June 26, 2003
----------------------------------------------------------------------------------------------------------------
                                                                                    Critical/semi-
           Medical       Device type      21 CFR      Class     Product     Risk*      critical/      Premarket
          specialty                       section                code                 noncritical      exempt
----------------------------------------------------------------------------------------------------------------
1       Cardio        Cardiopulmonary   unclassifi  ........  MAB         1         C               N\1\
                       Bypass Marker     ed
----------------------------------------------------------------------------------------------------------------
2       Cardio        Percutaneous &    post-       III       LOX         3         C               N
                       Operative         amendment
                       Transluminal
                       Coronary
                       Angioplasty
                       Catheter (PTCA)
----------------------------------------------------------------------------------------------------------------
3       Cardio        Percutaneous      post-       III       LPB         3         C               N
                       Ablation          amendment
                       Electrode
----------------------------------------------------------------------------------------------------------------
4       Cardio        Peripheral        unclassifi  ........  LIT         3         C               N
                       Transluminal      ed
                       Angioplasty
                       (PTA) Catheter
----------------------------------------------------------------------------------------------------------------
5       Cardio        Blood-Pressure    870.1120    II        DXQ         1         N               N
                       Cuff
----------------------------------------------------------------------------------------------------------------
6       Cardio        Angiography       870.1200    II        DQO         3         C               N
                       Catheter
----------------------------------------------------------------------------------------------------------------
7       Cardio        Electrode         870.1220    II        DRF         3         C               N
                       Recording
                       Catheter
----------------------------------------------------------------------------------------------------------------
8       Cardio        High-Density      870.1220    II        MTD         3         C               N
                       Array Catheter
----------------------------------------------------------------------------------------------------------------
9       Cardio        Fiberoptic        870.1230    II        DQE         3         C               N
                       Oximeter
                       Catheter
----------------------------------------------------------------------------------------------------------------
10      Cardio        Steerable         870.1280    II        DRA         3         C               N
                       Catheter
----------------------------------------------------------------------------------------------------------------
11      Cardio        Steerable         870.1290    II        DXX         3         C               N
                       Catheter
                       Control System
----------------------------------------------------------------------------------------------------------------
12      Cardio        Guide Wire        870.1330    II        DQX         3         C               N
----------------------------------------------------------------------------------------------------------------
13      Cardio        Angiographic      870.1390    II        DRC         3         C               N
                       Needle
----------------------------------------------------------------------------------------------------------------
14      Cardio        Trocar            870.1390    II        DRC         3         C               N
----------------------------------------------------------------------------------------------------------------
15      Cardio        Syringes          870.1650    II        DXT         3         C               N
----------------------------------------------------------------------------------------------------------------
16      Cardio        Injector Type     870.1670    II        DQF         3         C               N
                       Syringe
                       Actuator
----------------------------------------------------------------------------------------------------------------
17      Cardio        Oximeter          870.2700    II        DQA         3         N               N
----------------------------------------------------------------------------------------------------------------
18      Cardio        Tissue            870.2700    II        MUD         3         C               N
                       Saturation
                       Oximeter
----------------------------------------------------------------------------------------------------------------
19      Cardio        Intra-Aortic      870.3535    III       DSP         3         C               N
                       Balloon System
----------------------------------------------------------------------------------------------------------------
20      Cardio        Vascular Clamp    870.4450    II        DXC         3         C               N
----------------------------------------------------------------------------------------------------------------
21      Cardio        Device,           870.4500    I         MWS         2         C               Y\2\
                       Stabilizer,
                       Heart
----------------------------------------------------------------------------------------------------------------
22      Cardio        External Vein     870.4885    II        DWQ         3         C               N
                       Stripper
----------------------------------------------------------------------------------------------------------------
23      Cardio        Compressible      870.5800    II        JOW         1         N               N
                       Limb Sleeve
----------------------------------------------------------------------------------------------------------------
24      Dental        Bur               872.3240    I         EJL         1         C               Y
----------------------------------------------------------------------------------------------------------------
25      Dental        Diamond Coated    872.3240    I         EJL         3         C               Y
                       Bur
----------------------------------------------------------------------------------------------------------------
26      Dental        Diamond           872.4535    I         DZP         3         C               Y
                       Instrument
----------------------------------------------------------------------------------------------------------------
27      Dental        AC-Powered Bone   872.4120    II        DZH         2         C               N
                       Saw
----------------------------------------------------------------------------------------------------------------
28      Dental        Manual Bone       872.4120    II        DZJ         2         C               N
                       Drill and Wire
                       Driver
----------------------------------------------------------------------------------------------------------------
29      Dental        Powered Bone      872.4120    II        DZI         2         C               N
                       Drill
----------------------------------------------------------------------------------------------------------------
30      Dental        Intraoral Drill   872.4130    I         DZA         1         C               Y
----------------------------------------------------------------------------------------------------------------
31      Dental        Injection needle  872.4730    I         DZM         3         C               Y
----------------------------------------------------------------------------------------------------------------
32      Dental        Metal             872.5410    I         EJF         3         S               Y
                       Orthodontic
                       Bracket
----------------------------------------------------------------------------------------------------------------

[[Page 38077]]

 
33      Dental        Plastic           872.5470    II        DYW         3         S               N
                       Orthodontic
                       Bracket
----------------------------------------------------------------------------------------------------------------
34      ENT           Bur               874.4140    I         EQJ         1         C               Y
----------------------------------------------------------------------------------------------------------------
35      ENT           Diamond Coated    874.4140    I         EQJ         3         C               Y
                       Bur
----------------------------------------------------------------------------------------------------------------
36      ENT           Microdebrider     874.4140    I         EQJ         3         C               Y
----------------------------------------------------------------------------------------------------------------
37      ENT           Microsurgical     874.4490    II        LMS         1         S               N
                       Argon Fiber
                       Optic Laser
                       Cable, for Uses
                       Other Than
                       Otology,
                       Including
                       Laryngology and
                       General Use in
                       Otolaryngology
----------------------------------------------------------------------------------------------------------------
38      ENT           Microsurgical     874.4490    II        LXR         1         S               N
                       Argon Fiber
                       Optic Laser
                       Cable for Use
                       in Otology
----------------------------------------------------------------------------------------------------------------
39      ENT           Microsurgical     874.4500    II        EWG         1         S               N
                       Carbon-Dioxide
                       Fiber Optic
                       Laser Cable
----------------------------------------------------------------------------------------------------------------
40      ENT           Bronchoscope      874.4680    II        BWH         3         C               N
 [dagg                 Biopsy Forceps
 er]                   (Nonrigid)
----------------------------------------------------------------------------------------------------------------
41      ENT           Bronchoscope      874.4680    II        JEK         1         C               N
 [dagg                 Biopsy Forceps
 er]                   (Rigid)
----------------------------------------------------------------------------------------------------------------
42      Gastro/       Biopsy Forceps    876.1075    I         FFF         1         C               Y
 [dagg   Urology       Cover
 er]
----------------------------------------------------------------------------------------------------------------
43      Gastro/       Biopsy            876.1075    II        KNW         3         C               N
 [dagg   Urology       Instrument
 er]
----------------------------------------------------------------------------------------------------------------
44      Gastro/       Biopsy Needle     876.1075    II        FCG         3         C               N
 [dagg   Urology       Set
 er]
----------------------------------------------------------------------------------------------------------------
45      Gastro/       Biopsy Punch      876.1075    II        FCI         2         C               N
 [dagg   Urology
 er]
----------------------------------------------------------------------------------------------------------------
46      Gastro/       Mechanical        876.1075    II        FCF         2         C               N
 [dagg   Urology       Biopsy
 er]                   Instrument
----------------------------------------------------------------------------------------------------------------
47      Gastro/       Nonelectric       876.1075    I         FCL         3         C               Y
 [dagg   Urology       Biopsy Forceps
 er]
----------------------------------------------------------------------------------------------------------------
48      Gastro/       Cytology Brush    876.1500    II        FDX         2         S               N
         Urology       for Endoscope
----------------------------------------------------------------------------------------------------------------
49      Gastro/       Endoscope         876.1500    II        KOG         2         S               N
         Urology       accessories
----------------------------------------------------------------------------------------------------------------
50      Gastro/       Extraction        876.1500    II        KOG         2         S               N
         Urology       Balloons/
                       Baskets
----------------------------------------------------------------------------------------------------------------
51      Gastro/       Endoscopic        876.1500    II        FBK         3         C               N
         Urology       needle
----------------------------------------------------------------------------------------------------------------
52      Gastro/       Simple            876.1500    II        FHP         3         C               N
         Urology       Pneumoperitoneu
                       m Needle
----------------------------------------------------------------------------------------------------------------
53      Gastro/       Spring Loaded     876.1500    II        FHO         3         C               N
         Urology       Pneumoperitoneu
                       m Needle
----------------------------------------------------------------------------------------------------------------
54      Gastro/       Active            876.4300    II        FAS         3         S               N
         Urology       Electrosurgical
                       Electrode
----------------------------------------------------------------------------------------------------------------
55      Gastro/       Biliary           876.5010,   II        FGE         3         C               N
 [dagg   Urology       Sphincterotomes   876.1500
 er]
----------------------------------------------------------------------------------------------------------------
56      Gastro/       Electric Biopsy   876.4300    II        KGE         3         C               N
         Urology       Forceps
----------------------------------------------------------------------------------------------------------------
57      Gastro/       Electrosurgical   876.4300    II        KNS         3         S               N
         Urology       Endoscopic Unit
                       (With or
                       Without
                       Accessories)
----------------------------------------------------------------------------------------------------------------
58      Gastro/       Flexible Snare    876.4300    II        FDI         3         S               N
         Urology
----------------------------------------------------------------------------------------------------------------
59      Gastro/       Flexible Suction  876.4300    II        FEH         3         S               N
         Urology       Coagulator
                       Electrode
----------------------------------------------------------------------------------------------------------------

[[Page 38078]]

 
60      Gastro/       Flexible Stone    876.4680    II        FGO         3         S               Y
         Urology       Dislodger
----------------------------------------------------------------------------------------------------------------
61      Gastro/       Metal Stone       876.4680    II        FFL         3         S               Y
         Urology       Dislodger
----------------------------------------------------------------------------------------------------------------
62      Gastro/       Needle Holder     876.4730    I         FHQ         1         C               Y
         Urology
----------------------------------------------------------------------------------------------------------------
63      Gastro/       Nonelectrical     876.4730    I         FGX         1         S               Y
         Urology       Snare
----------------------------------------------------------------------------------------------------------------
64      Gastro/       Urological        876.5130    II        KOD         2         S               N
         Urology       Catheter
----------------------------------------------------------------------------------------------------------------
65      Gastro/       Single Needle     876.5540    II        LBW, FIE    3         C               N
         Urology       Dialysis Set
----------------------------------------------------------------------------------------------------------------
66      Gastro/       Hemodialysis      876.5820    II        KOC         2         S               N
         Urology       Blood Circuit
                       Accessories
----------------------------------------------------------------------------------------------------------------
67      Gastro/       Single Needle     876.5820    II        FIF         3         C               N
         Urology       Dialysis Set
----------------------------------------------------------------------------------------------------------------
68      GE/U          Hemorrhoidal      876.4400    II        FHN         2         C               N
                       Ligator
----------------------------------------------------------------------------------------------------------------
69      General       Implanted,        post-       III       LKK         3         C               N
         Hospital      Programmable      amendment
                       Infusion Pump
----------------------------------------------------------------------------------------------------------------
70      General       Needle            post-       III       MTV         1         N               N
         Hospital      Destruction       amendment
                       Device
----------------------------------------------------------------------------------------------------------------
71      General       Nonpowered        880.5150    I         IKY         2         N               Y
         Hospital      Flotation
                       Therapy
                       Mattress
----------------------------------------------------------------------------------------------------------------
72      General       Non-AC-Powered    880.5510    I         FSA         2         N               Y
         Hospital      Patient Lift
----------------------------------------------------------------------------------------------------------------
73      General       Alternating       880.5550    II        FNM         1         N               Y
         Hospital      Pressure Air
                       Flotation
                       Mattress
----------------------------------------------------------------------------------------------------------------
74      General       Temperature       880.5560    I         FOH         2         N               Y
         Hospital      Regulated Water
                       Mattress
----------------------------------------------------------------------------------------------------------------
75      General       Hypodermic        880.5570    II        FMI         3         C               N
         Hospital      Single Lumen
                       Needle
----------------------------------------------------------------------------------------------------------------
76      General       Piston Syringe    880.5860    II        FMF         3         C               N
         Hospital
----------------------------------------------------------------------------------------------------------------
77      General       Mattress Cover    880.6190    I         FMW         2         N               Y
         Hospital      (Medical
                       Purposes)
----------------------------------------------------------------------------------------------------------------
78      General       Disposable        880.6820    I         JOK         1         N               Y
         Hospital      Medical
                       Scissors
----------------------------------------------------------------------------------------------------------------
79      General       Irrigating        880.6960    I         KYZ, KYY    1         C               Y
         Hospital      Syringe
----------------------------------------------------------------------------------------------------------------
80      Infection     Surgical Gowns    878.4040    II        FYA         1         C               N
         Control
----------------------------------------------------------------------------------------------------------------
81      Lab           Blood Lancet      878.4800    I         FMK         1         C               Y
----------------------------------------------------------------------------------------------------------------
82      Neuro         Clip Forming/     882.4190    I         HBS         3*        C               Y
                       Cutting
                       Instrument,
----------------------------------------------------------------------------------------------------------------
83      Neuro         Drills, Burrs,    882.4300    II        HBG         3*        C               N
                       Trephines, and
                       Accessories
                       (Manual)
----------------------------------------------------------------------------------------------------------------
84      Neuro         Drills, Burrs,    882.4305    II        HBF         3*        C               N
                       Trephines, and
                       Accessories
                       (Compound,
                       Powered)
----------------------------------------------------------------------------------------------------------------
85      Neuro         Drills, Burrs,    882.4310    II        HBE         3*        C               N
                       Trephines, and
                       Accessories
                       (Simple,
                       Powered)
----------------------------------------------------------------------------------------------------------------
86      OB/GYN        Oocyte            Unclassifi  II        MHK         3         C               N
                       Aspiration        ed
                       Needle
----------------------------------------------------------------------------------------------------------------
87      OB/GYN        Laparoscope       884.1720    I         HET         2         C               Y
                       Accessories
----------------------------------------------------------------------------------------------------------------

[[Page 38079]]

 
88      OB/GYN        Laparoscope       884.1720    II        HET         3         C               N
                       Accessories
----------------------------------------------------------------------------------------------------------------
89      OB/GYN        Laparoscopic      884.1720    I         HET         2         C               Y
                       Dissectors
----------------------------------------------------------------------------------------------------------------
90      OB/GYN        Laparoscopic      884.1720    I         HET         2         C               Y
                       Graspers
----------------------------------------------------------------------------------------------------------------
91      OB/GYN        Laparoscopic      884.1720    I         HET         2         C               Y
                       Scissors
----------------------------------------------------------------------------------------------------------------
92      OB/GYN        Insufflator       884.1730    II        HIF         3         C               Y
                       Accessories
                       (Tubing, Verres
                       Needle, Kits)
----------------------------------------------------------------------------------------------------------------
93      OB/GYN        Laparoscopic      884.1730    II        HIF         2         N               N
                       Insufflator
----------------------------------------------------------------------------------------------------------------
94      OB/GYN        Endoscopic        884.4100    II        HIM         2         N               N
                       Electrocautery
                       and Accessories
----------------------------------------------------------------------------------------------------------------
95      OB/GYN        Gynecologic       884.4120    II        HGI         2         N               N
                       Electrocautery
                       (and
                       Accessories)
----------------------------------------------------------------------------------------------------------------
96      OB/GYN        Endoscopic        884.4150    II        HIN         2         N               N
                       Bipolar
                       Coagulator-
                       Cutter (and
                       Accessories)
----------------------------------------------------------------------------------------------------------------
97      OB/GYN        Culdoscopic       884.4160    II        HFI         2         N               N
                       Coagulator (and
                       Accessories)
----------------------------------------------------------------------------------------------------------------
98      OB/GYN        Endoscopic        884.4160    II        KNF         2         N               N
                       Unipolar
                       Coagulator-
                       Cutter (and
                       Accessories)
----------------------------------------------------------------------------------------------------------------
99      OB/GYN        Hysteroscopic     884.4160    II        HFH         2         N               N
                       Coagulator (and
                       Accessories)
----------------------------------------------------------------------------------------------------------------
100     OB/GYN        Unipolar          884.4160    II        HFG         2         N               N
                       Laparoscopic
                       Coagulator (and
                       Accessories)
----------------------------------------------------------------------------------------------------------------
101     OB/GYN        Episiotomy        884.4520    I         HDK         1         C               Y
                       Scissors
----------------------------------------------------------------------------------------------------------------
102     OB/GYN        Umbilical         884.4520    I         HDJ         1         C               Y
                       Scissors
----------------------------------------------------------------------------------------------------------------
103     OB/GYN        Biopsy Forceps    884.4530    I         HFB         3         C               Y
----------------------------------------------------------------------------------------------------------------
104     OB/GYN        Assisted          884.6100    II        MQE         3         C               N
                       Reproduction
                       Needles
----------------------------------------------------------------------------------------------------------------
105     Ophthalmic    Endoilluminator   876.1500    II        MPA         3*        C               N
----------------------------------------------------------------------------------------------------------------
106     Ophthalmic    Surgical Drapes   878.4370    II        KKX         2         C               N
----------------------------------------------------------------------------------------------------------------
107     Ophthalmic    Ophthalmic Knife  886.4350    I         HNN         3         C               Y
----------------------------------------------------------------------------------------------------------------
108     Ophthalmic    Keratome Blade    886.4370    I not     HMY, HNO    3         C               N
                                                     exempt
----------------------------------------------------------------------------------------------------------------
109     Ophthalmic    Phacoemulsificat  886.4670    II        HQC         3         C               N
                       ion Needle
----------------------------------------------------------------------------------------------------------------
110     Ophthalmic    Phacoemulsificat  886.4670    II        MUS         2         C               N
                       ion/
                       Phacofragmentat
                       ion Fluidic
----------------------------------------------------------------------------------------------------------------
111     Ophthalmic    Phacofragmentati  886.4670    II        HQC         1         N               N
                       on Unit
----------------------------------------------------------------------------------------------------------------
112     Ortho         Saw Blades        878.4820    I         GFA, DWH,   1         C               Y
                                                               GEY, GET
----------------------------------------------------------------------------------------------------------------
113     Ortho         Surgical Drills   878.4820    I         GEY, GET    1         C               Y
----------------------------------------------------------------------------------------------------------------
114     Ortho         Arthroscope       888.1100    II        HRX         2         C               Y
                       accessories
----------------------------------------------------------------------------------------------------------------

[[Page 38080]]

 
115     Ortho         Bone Tap          888.4540    I         HWX         1         C               Y
----------------------------------------------------------------------------------------------------------------
116     Ortho         Burr              888.4540    I         HTT         1         C               Y
----------------------------------------------------------------------------------------------------------------
117     Ortho         Carpal Tunnel     888.4540    I         LXH         2         C               Y
                       Blade
----------------------------------------------------------------------------------------------------------------
118     Ortho         Countersink       888.4540    I         HWW         1         C               Y
----------------------------------------------------------------------------------------------------------------
119     Ortho         Drill Bit         888.4540    I         HTW         1         C               Y
----------------------------------------------------------------------------------------------------------------
120     Ortho         Knife             888.4540    I         HTS         1         C               Y
----------------------------------------------------------------------------------------------------------------
121     Ortho         Manual Surgical   888.4540    I         LXH         1         C               Y
                       Instrument
----------------------------------------------------------------------------------------------------------------
122     Ortho         Needle Holder     888.4540    I         HXK         1         C               Y
----------------------------------------------------------------------------------------------------------------
123     Ortho         Reamer            888.4540    I         HTO         1         C               Y
----------------------------------------------------------------------------------------------------------------
124     Ortho         Rongeur           888.4540    I         HTX         1         C               Y
----------------------------------------------------------------------------------------------------------------
125     Ortho         Scissors          888.4540    I         HRR         1         C               Y
----------------------------------------------------------------------------------------------------------------
126     Ortho         Staple Driver     888.4540    I         HXJ         1         C               Y
----------------------------------------------------------------------------------------------------------------
127     Ortho         Trephine          888.4540    I         HWK         1         C               Y
----------------------------------------------------------------------------------------------------------------
128     Ortho         Flexible Reamers/ 886.4070    I         GEY, HRG    1         C               Y
                       Drills           878.4820
----------------------------------------------------------------------------------------------------------------
129     Ortho         External          888.3040    II        JEC, KTW,   2         N               N
                       Fixation Frame   888.3030               KTT
----------------------------------------------------------------------------------------------------------------
130     Physical      Non-Heating Lamp  unclassifi  ........  NHN         1         N               N
         Medicine      for Adjunctive    ed
                       Use Inpatient
                       Therapy
----------------------------------------------------------------------------------------------------------------
131     Physical      Electrode Cable   890.1175    II        IKD         1         N               Y
         Medicine
----------------------------------------------------------------------------------------------------------------
132     Physical      External Limb     890.3420    I         ISL         2         N               Y
         Medicine      Component, Hip
                       Joint
----------------------------------------------------------------------------------------------------------------
133     Physical      External Limb     890.3420    I         ISY         2         N               Y
         Medicine      Component, Knee
                       Joint
----------------------------------------------------------------------------------------------------------------
134     Physical      External Limb     890.3420    I         ISZ         2         N               Y
         Medicine      Component,
                       Mechanical
                       Wrist
----------------------------------------------------------------------------------------------------------------
135     Physical      External Limb     890.3420    I         IQQ         2         N               Y
         Medicine      Component,
                       Shoulder Joint
----------------------------------------------------------------------------------------------------------------
136     Plastic       Stapler           878.4800    I         GAG, GEF,   2         C               Y
         Surgery                                               FHM, HBT
----------------------------------------------------------------------------------------------------------------
137     Radiology     Isotope Needle    892.5730    II        IWF         3         C               N
----------------------------------------------------------------------------------------------------------------
138     Resp          Endotracheal      unclassifi  III       LNZ         3         C               N
                       Tube Changer      ed
----------------------------------------------------------------------------------------------------------------
139     Resp          Anesthesia        868.5150    II        BSP         3         C               N
                       conduction
                       needle
----------------------------------------------------------------------------------------------------------------
140     Resp          Short term        868.5150    II        MIA         3         C               N
                       spinal needle
----------------------------------------------------------------------------------------------------------------
141     Resp          Respiratory       868.5240    I         CAI         2         S               Y
                       Therapy and
                       Anesthesia
                       Breathing
                       Circuits
----------------------------------------------------------------------------------------------------------------
142     Resp          Oral and Nasal    868.5350    I         BZB         1         C               Y
                       Catheters
----------------------------------------------------------------------------------------------------------------
143     Resp          Gas Masks         868.5550    I         BSJ         1         S               Y
----------------------------------------------------------------------------------------------------------------
144     Resp          Breathing         868.5620    I         BYP         1         N               Y
                       Mouthpiece
----------------------------------------------------------------------------------------------------------------

[[Page 38081]]

 
145     Resp          Tracheal Tube     868.5730    II        BTR         3         C               N
----------------------------------------------------------------------------------------------------------------
146     Resp          Airway Connector  868.5810    I         BZA         2         S               Y
----------------------------------------------------------------------------------------------------------------
147     Resp          CPAP Mask         868.5905    II        BZD         3         S               N
----------------------------------------------------------------------------------------------------------------
148     Resp          Emergency Manual  868.5915    II        BTM         2         S               N
                       Resuscitator
----------------------------------------------------------------------------------------------------------------
149     Resp          Tracheobronchial  868.6810    I         BSY         3         S               Y
                       Suction
                       Catheter
----------------------------------------------------------------------------------------------------------------
150     Surgery       AC-Powered        unclassifi  ........  HWE         2         C               N
                       Orthopedic        ed
                       Instrument and
                       Accessories
----------------------------------------------------------------------------------------------------------------
151     Surgery       Breast Implant    unclassifi  ........  MRD         1         C               N
                       Mammary Sizer     ed
----------------------------------------------------------------------------------------------------------------
152     Surgery       Ultrasonic        unclassifi  ........  LFL         3         C               N
                       Surgical          ed
                       Instrument
----------------------------------------------------------------------------------------------------------------
153     Surgery       Trocar            874.4420    I         KAB, KBG,   3         C               Y
                                                               KCI
----------------------------------------------------------------------------------------------------------------
154     Surgery       Endoscopic        876.1500    II        GCP, GCR    2         C               N
                       Blades
----------------------------------------------------------------------------------------------------------------
155     Surgery       Endoscopic        876.1500    II        GCP, GCR    1         C               N
                       Guidewires
----------------------------------------------------------------------------------------------------------------
156     Surgery       Inflatable        878.3900    I         FZF         1         N               Y
                       External
                       Extremity
                       Splint
----------------------------------------------------------------------------------------------------------------
157     Surgery       Noninflatable     878.3910    I         FYH         1         N               Y
                       External
                       Extremity
                       Splint
----------------------------------------------------------------------------------------------------------------
158     Surgery       Catheter Needle   878.4200    I         GCB         3         C               Y
----------------------------------------------------------------------------------------------------------------
159     Surgery       Implantable Clip  878.4300    II        FZP         3         C               N
----------------------------------------------------------------------------------------------------------------
160     Surgery       Electrosurgical   878.4400    II        BWA         2         C               N
                       and Coagulation
                       Unit With
                       Accessories
----------------------------------------------------------------------------------------------------------------
161     Surgery       Electrosurgical   878.4400    II        HAM         2         C               N
                       Apparatus
----------------------------------------------------------------------------------------------------------------
162     Surgery       Electrosurgical   878.4400    II        GEI         2         C               N
                       Cutting and
                       Coagulation
                       Device and
                       Accessories
----------------------------------------------------------------------------------------------------------------
163     Surgery       Electrosurgical   878.4400    II        DWG         2         C               N
                       Device
----------------------------------------------------------------------------------------------------------------
164     Surgery       Electrosurgical   878.4400    II        JOS         2         C               N
                       Electrode
----------------------------------------------------------------------------------------------------------------
165     Surgery       Implantable       878.4750    II        GDW         3         C               N
                       Staple, Clamp,
                       Clip for
                       Suturing
                       Apparatus
----------------------------------------------------------------------------------------------------------------
166     Surgery       Percutaneous      878.4800    I         MJG         3         C               Y
                       Biopsy Device
----------------------------------------------------------------------------------------------------------------
167     Surgery       Gastro-Urology    878.4800    I         FHR         3         C               Y
                       Needle
----------------------------------------------------------------------------------------------------------------
168     Surgery       Aspiration and    878.4800    I         GAA         3         C               Y
                       Injection
                       Needle
----------------------------------------------------------------------------------------------------------------
169     Surgery       Biopsy Brush      878.4800    I         GEE         1         C               Y
----------------------------------------------------------------------------------------------------------------
170     Surgery       Blood Lancet      878.4800    I         FMK         1         C               Y
----------------------------------------------------------------------------------------------------------------
171     Surgery       Bone Hook         878.4800    I         KIK         1         C               Y
----------------------------------------------------------------------------------------------------------------
172     Surgery       Cardiovascular    878.4800    I         DWO         3         C               Y
                       Biopsy Needle
----------------------------------------------------------------------------------------------------------------
173     Surgery       Clamp             878.4800    I         GDJ         1         C               Y
----------------------------------------------------------------------------------------------------------------
174     Surgery       Clamp             878.4800    I         HXD         1         C               Y
----------------------------------------------------------------------------------------------------------------

[[Page 38082]]

 
175     Surgery       Curette           878.4800    I         HTF         1         C               Y
----------------------------------------------------------------------------------------------------------------
176     Surgery       Disposable        878.4800    I         KDC         1         C               Y
                       Surgical
                       Instrument
----------------------------------------------------------------------------------------------------------------
177     Surgery       Disposable Vein   878.4800    I         GAJ         1         C               Y
                       Stripper
----------------------------------------------------------------------------------------------------------------
178     Surgery       Dissector         878.4800    I         GDI         1         C               Y
----------------------------------------------------------------------------------------------------------------
179     Surgery       Forceps           878.4800    I         GEN         2         C               Y
----------------------------------------------------------------------------------------------------------------
180     Surgery       Forceps           878.4800    I         HTD         2         C               Y
----------------------------------------------------------------------------------------------------------------
181     Surgery       Gouge             878.4800    I         GDH         1         C               Y
----------------------------------------------------------------------------------------------------------------
182     Surgery       Hemostatic Clip   878.4800    I         HBT         2         C               Y
                       Applier
----------------------------------------------------------------------------------------------------------------
183     Surgery       Hook              878.4800    I         GDG         1         C               Y
----------------------------------------------------------------------------------------------------------------
184     Surgery       Manual            878.4800    I         MDM, MDW    1         C               Y
                       Instrument
----------------------------------------------------------------------------------------------------------------
185     Surgery       Manual Retractor  878.4800    I         GZW         1         C               Y
----------------------------------------------------------------------------------------------------------------
186     Surgery       Manual Saw and    878.4800    I         GDR, HAC    1         C               Y
                       Accessories
----------------------------------------------------------------------------------------------------------------
187     Surgery       Manual Saw and    878.4800    I         HAC         1         C               Y
                       Accessories
----------------------------------------------------------------------------------------------------------------
188     Surgery       Manual Surgical   878.4800    I         FZO         1         C               Y
                       Chisel
----------------------------------------------------------------------------------------------------------------
189     Surgery       Mastoid Chisel    878.4800    I         JYD         1         C               Y
----------------------------------------------------------------------------------------------------------------
190     Surgery       Orthopedic        878.4800    I         HTZ         1         C               Y
                       Cutting
                       Instrument
----------------------------------------------------------------------------------------------------------------
191     Surgery       Orthopedic        878.4800    I         HXR         1         C               Y
                       Spatula
----------------------------------------------------------------------------------------------------------------
192     Surgery       Osteotome         878.4800    I         HWM         1         C               Y
----------------------------------------------------------------------------------------------------------------
193     Surgery       Rasp              878.4800    I         GAC         1         C               Y
----------------------------------------------------------------------------------------------------------------
194     Surgery       Rasp              878.4800    I         HTR         1         C               Y
----------------------------------------------------------------------------------------------------------------
195     Surgery       Retractor         878.4800    I         GAD         1         C               Y
----------------------------------------------------------------------------------------------------------------
196     Surgery       Retractor         878.4800    I         HXM         1         C               Y
----------------------------------------------------------------------------------------------------------------
197     Surgery       Saw               878.4800    I         HSO         1         C               Y
----------------------------------------------------------------------------------------------------------------
198     Surgery       Scalpel Blade     878.4800    I         GES         1         C               Y
----------------------------------------------------------------------------------------------------------------
199     Surgery       Scalpel Handle    878.4800    I         GDZ         1         C               Y
----------------------------------------------------------------------------------------------------------------
200     Surgery       Scissors          878.4800    I         LRW         1         C               Y
----------------------------------------------------------------------------------------------------------------
201     Surgery       Snare             878.4800    I         GAE         1         C               Y
----------------------------------------------------------------------------------------------------------------
202     Surgery       Spatula           878.4800    I         GAF         1         C               Y
----------------------------------------------------------------------------------------------------------------
203     Surgery       Staple Applier    878.4800    I         GEF         2         C               Y
----------------------------------------------------------------------------------------------------------------
204     Surgery       Stapler           878.4800    I         GAG         2         C               Y
----------------------------------------------------------------------------------------------------------------
205     Surgery       Stomach and       878.4800    I         FHM         2         C               Y
                       Intestinal
                       Suturing
                       Apparatus
----------------------------------------------------------------------------------------------------------------
206     Surgery       Surgical Curette  878.4800    I         FZS         1         C               Y
----------------------------------------------------------------------------------------------------------------
207     Surgery       Surgical Cutter   878.4800    I         FZT         1         C               Y
----------------------------------------------------------------------------------------------------------------
208     Surgery       Surgical Knife    878.4800    I         EMF         1         S               Y
----------------------------------------------------------------------------------------------------------------
209     Surgery       Laser Powered     878.4810    II        GEX         2         C               N
                       Instrument
----------------------------------------------------------------------------------------------------------------

[[Page 38083]]

 
210     Surgery       Ac-Powered Motor  878.4820    I         GEY         2         C               Y
----------------------------------------------------------------------------------------------------------------
211     Surgery       Bit               878.4820    I         GFG         1         C               Y
----------------------------------------------------------------------------------------------------------------
212     Surgery       Bur               878.4820    I         GFF, GEY    1         C               Y
----------------------------------------------------------------------------------------------------------------
213     Surgery       Cardiovascular    878.4820    I         DWH         1         C               Y
                       Surgical Saw
                       Blade
----------------------------------------------------------------------------------------------------------------
214     Surgery       Chisel            878.4820    I         KDG         1         C               Y
                       (Osteotome)
----------------------------------------------------------------------------------------------------------------
215     Surgery       Dermatome         878.4820    I         GFD         1         C               Y
----------------------------------------------------------------------------------------------------------------
216     Surgery       Electrically      878.4820    I         DWI         2         C               Y
                       Powered Saw
----------------------------------------------------------------------------------------------------------------
217     Surgery       Pneumatic         878.4820    I         GET         2         C               Y
                       Powered Motor
----------------------------------------------------------------------------------------------------------------
218     Surgery       Pneumatically     878.4820    I         KFK         2         C               Y
                       Powered Saw
----------------------------------------------------------------------------------------------------------------
219     Surgery       Powered Saw and   878.4820    I         HAB         2         C               Y
                       Accessories
----------------------------------------------------------------------------------------------------------------
220     Surgery       Saw Blade         878.4820    I         GFA         1         C               Y
----------------------------------------------------------------------------------------------------------------
221     Surgery       Nonpneumatic      878.5900    I         GAX         1         N               Y
                       Tourniquet
----------------------------------------------------------------------------------------------------------------
222     Surgery       Pneumatic         878.5910    I         KCY         1         N               Y
                       Tourniquet
----------------------------------------------------------------------------------------------------------------
223     Surgery       Endoscopic        888.4540    I         HXJ         2         C               Y
                       Staplers
----------------------------------------------------------------------------------------------------------------
224     Surgery       Trocar            876.1500    II        GCJ, DRC    3         C               N
                                        870.1390
----------------------------------------------------------------------------------------------------------------
225     Surgery       Surgical Cutting  878.4800    I         GDZ, GDX,   2         C               Y
                       Accessories      874.4420               GES, KBQ,
                                                               KAS
----------------------------------------------------------------------------------------------------------------
226     Surgery       Electrosurgical   876.4300    II        HAM, GEI,   2         C               N
                       Electrodes/      878.4400               FAS
                       Handles/Pencils
----------------------------------------------------------------------------------------------------------------
227     Surgery       Scissor Tips      878.4800    I         LRW, HDK,   2         C               Y
                                        884.4520               HDJ, JZB,
                                        874.4420               KBD
----------------------------------------------------------------------------------------------------------------
228     Surgery       Laser Fiber       878.4810    II        GEX, EWG,   1         C               N
                       Delivery         874.4500               LLW, HQF,
                       Systems          886.4390               HHR, HQB
                                        884.4550
                                        886.4690
----------------------------------------------------------------------------------------------------------------
\1\ N means no.
\2\ Y means yes.
[dagger] Indicates a change since last publication.


    Dated: June 20, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16109 Filed 6-25-03; 8:45 am]
BILLING CODE 4160-01-S