[Federal Register Volume 68, Number 83 (Wednesday, April 30, 2003)]
[Notices]
[Pages 23139-23148]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 03-10413]


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

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 announcing the 
availability of a list (List I) of critical reprocessed single-use 
devices (SUDs) whose exemption from premarket submission 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)); and a list (List II) of 
reprocessed SUDs that are currently subject to 510(k) requirements for 
which FDA has determined that validation data, as specified under 
MDUFMA, is necessary in a 510(k). FDA is requiring submission of these 
data to ensure that these reprocessed SUDs are substantially equivalent 
to predicate devices in accordance with MDUFMA.

DATES: These actions are effective April 30, 2003. Manufacturers of 
SUDs identified in List I whose exemption is being terminated must 
submit 510(k)s for these devices by July 30, 2004, or their devices may 
no longer be marketed. Manufacturers who already have clearance letters 
for SUDs identified in List II must submit validation data for these 
devices by January 30, 2004, or marketing of these devices must cease.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(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 on Lists I and II 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 (Pub. L. 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 are currently subject to cleared 510(k)s also will 
need to submit the validation data specified by the agency.
    In the near future, FDA will publish a guidance document providing 
more specific information about the types of validation data that 
should be submitted in premarket notification submissions for the 
reprocessed SUDs listed in this notice.

A. Definitions

    Under section 302(b) 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 in

[[Page 23140]]

the industry.\1\ These categories of devices are defined as follows:
---------------------------------------------------------------------------

    \1\ 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, 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.
1. 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 must identify in a Federal Register notice those critical 
reprocessed SUDs whose exemption from premarket notification will be 
terminated. List I in this Federal Register notice implements this 
MDUFMA requirement.
    In accordance with MDUFMA, manufacturers of the devices identified 
in List I 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 Sec.  807.87 (21 
CFR 807.87), within 15 months of publication of this notice or no 
longer market their device.
2. Requirements for Semicritical Reprocessed SUDs
    MDUFMA also requires FDA to review the semicritical 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. FDA must 
identify these devices in a notice published in the Federal Register by 
April 26, 2004. Manufacturers of devices identified at that time will 
be required to 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 Sec.  807.87, 
within 15 months of publication of that notice or no longer market 
their device.

3. Requirements for Noncritical Reprocessed SUDs

    MDUFMA does not require FDA to take any action under this section 
for noncritical SUDs that are exempt from premarket submission 
requirements.

C. Reprocessed SUDs Already Subject to Premarket Notification 
Requirements

    MDUFMA also requires FDA to review the types of reprocessed SUDs 
already subject to premarket notification requirements and to identify 
which of these devices require the submission of validation data to 
ensure their substantial equivalence to predicate devices. FDA must 
publish a list of these devices in the Federal Register by April 26, 
2003, and update the list as necessary. List II of this Federal 
Register notice implements this MDUFMA requirement. The devices on List 
II may be critical, semicritical, or noncritical reprocessed SUDs.
    1. For devices identified in List II that have not yet been cleared 
through the 510(k) process, manufacturers 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 Sec.  807.87, upon publication of this notice 
in order to market these devices. FDA will soon publish guidance to 
help submitters understand what types of validation data should be 
included in these 510(k)s.
    2. For devices identified in List II that already have been cleared 
through the 510(k) process, manufacturers must submit validation data 
regarding cleaning, sterilization, and functional performance within 
nine months of publication of this notice or marketing must cease. FDA 
will soon publish guidance to explain how a 510(k) holder may submit 
the additional data now being required to support an earlier clearance.

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

    FDA used a number of criteria to determine which device types 
should be included in the lists required by MDUFMA. As part of its 
consideration, FDA relied upon the Review Prioritization Scheme (RPS) 
it described in the February 2000 draft guidance document entitled 
``Reprocessing and Reuse of Single-Use Devices: Review Prioritization 
Scheme.'' \2\ In the RPS guidance, FDA set forth factors that could be 
used to evaluate risk associated with reprocessed SUDs. This approach 
assigned an overall risk to each SUD based on: (1) The risk of 
infection and (2) the risk of inadequate performance following 
reprocessing. Based on these risk factors, three categories of risk 
(high, moderate, and low) were developed. The designation of ``high 
risk'' was assigned to those devices that posed the greatest risk of 
infection and inadequate performance after reprocessing. In response to 
several comments about potential subjectivity of the RPS, FDA did not 
use the RPS approach when the agency finalized its enforcement 
priorities for reprocessed SUDs on August 14, 2000.
---------------------------------------------------------------------------

    \2\ This draft guidance document is available on the CDRH Web 
site at http//www.fda.gov/cdrh/reuse/1156.pdf.
---------------------------------------------------------------------------

    FDA has determined, however, that the RPS is an appropriate risk-
based tool for developing the lists required by MDUFMA because the RPS 
identifies the devices that are likely to raise the most concerns about 
both infection transmission and inadequate performance following 
reprocessing. In formulating these lists, the agency also had the 
benefit of comments from stakeholders and an internal centerwide 
committee to evaluate the results of the RPS and ensure its 
consistency. In addition, there was a final review of all the devices 
on these lists by the Director of the Office of Device Evaluation. In 
this context, the agency believes these steps have adequately addressed 
concerns about the subjectivity of the RPS.
    In addition to the previous criterion, FDA used one other criterion 
to identify those reprocessed SUDs that will be subject to the new 
requirements established by MDUFMA. The agency has included in these 
lists all 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 ophthalmology. This criterion was included in FDA's 
evaluation because insufficient scientific information exists at this 
time to establish standard methods to eliminate CJD infectious agents.
    Therefore, in order to develop the two lists required by MDUFMA, 
FDA used the following process. First, the agency identified the types 
of SUDs that are being reprocessed. FDA did this by searching the 
510(k) database for any 510(k)s that had been submitted for reprocessed 
SUDs and by asking original equipment manufacturers and reprocessors to 
provide information about types of devices that were being reprocessed. 
Second, FDA determined whether these devices are ``critical,'' ``semi-
critical,'' or ``non-critical''. (These

[[Page 23141]]

definitions reflect the Spaulding \3\ classification and are the same 
definitions FDA used earlier in developing its RPS.) FDA then applied 
the criteria described previously and ``listed'' any reprocessed SUD 
that was 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.
---------------------------------------------------------------------------

    \3\ 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, 1971:254-
274.
---------------------------------------------------------------------------

    All devices identified in List I (previously exempt from 510(k)) 
have been determined to be critical reprocessed SUDs. In addition to 
being critical, they are either high risk according to the RPS or 
intended to come in contact with tissue at high risk of being infected 
with CJD. It should be noted that not all exempt devices that are 
critical have been listed. Critical reprocessed SUDs that are not 
listed in List I at this time may be reconsidered in subsequent updates 
of the list. The devices in List II (devices currently subject to 
510(k) requirements that now will require the submission of validation 
data) are 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.
    FDA has also provided a reference list in Attachment 1. To show how 
FDA evaluated the risk of a specific device, Attachment 1 includes the 
entire group of devices FDA considered when identifying the reprocessed 
SUDs in Lists I and II, and shows how FDA applied the criteria that 
determined whether the device would be identified on either of these 
lists.
    In the Federal Register of February 4, 2003 (68 FR 5643), FDA 
invited interested persons to provide information and share views on 
the implementation of MDUFMA. The agency received several comments that 
identified specific reprocessed SUDs to be included in Lists I and II. 
The agency considered these recommendations while finalizing this 
document. Although FDA's lists do not include all the reprocessed SUDs 
that were recommended, the agency believes that those devices that pose 
the greatest risk of infection transmission and inadequate performance 
have been identified. The agency recognizes, however, that these lists 
may need to be re-evaluated and updated over time. Therefore, FDA will 
consider comments from the public on additional devices that should be 
included in the lists at any time. The agency also notes that MDUFMA 
permits FDA to request validation data for a device type that is 
subject to 510(k) clearance but not yet included in List II. If this 
were to occur, FDA would ensure that manufacturers were aware of this 
change in the 510(k) submission requirements for that type of device by 
promptly updating the list.
    Finally, FDA received one comment that suggested the agency's prior 
determinations about risk associated with reprocessed SUDs precluded 
FDA from now requiring 510(k)s for devices that were previously exempt 
or additional data for devices that were already cleared. FDA believes 
that this comment ignores the existence of MDUFMA's requirements. It is 
true that FDA had initially developed a regulatory approach for 
reprocessed SUDs that sought to treat those devices and original 
devices in a similar manner and that FDA had not required additional 
data to be submitted for certain reprocessed SUDs under that approach. 
However, through MDUFMA Congress clearly stated its intent to have the 
agency re-examine its policy with respect to reprocessed SUDs and 
legislated additional controls for those devices. FDA is committed to 
fulfilling its responsibilities under MDUFMA. The development and 
publication of these lists is part of the agency's implementation of 
these new statutory provisions.

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 26, 2004]
----------------------------------------------------------------------------------------------------------------
                                                                                              Product code name
 21 CFR section   Classification name    Product code for Non-         Product code for        for reprocessed
                                           reprocessed device         reprocessed device            device
----------------------------------------------------------------------------------------------------------------
872.3240........  Dental bur.........  Diamond Coated             NME                        Dental diamond
                                                                                              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 bur.                                                                microdebrider.
874.4140........  Ear, nose, and       Diamond Coated             NLZ                        ENT diamond coated
                   throat bur.                                                                bur.
874.4420........  Ear, nose, throat    KAB, KBG, KCI              NLB                        Laryngeal, Sinus,
                   manual surgical *                                                          Tracheal trocar.
                   * *.
878.4200........  Introduction/        GCB                        NMT                        Catheter needle.
                   drainage catheter
                   and accessories.
878.4800........  Manual surgical      MJG                        NNA                        Percutaneous biopsy
                   instrument.                                                                device.
878.4800........  Manual surgical      FHR                        NMU                        Gastro-Urology
                   instrument.                                                                needle.
878.4800........  Manual surgical      DWO                        NLK                        Cardiovascular
                   instrument for * *                                                         biopsy needle.
                   *.
878.4800........  Manual surgical      GAA                        NNC                        Aspiration and
                   instrument for * *                                                         injection.
                   *.
882.4190........  Forming/cutting      HBS                        NMN                        Forming/cutting
                   clip instrument.                                                           clip instrument.
884.1730........  Laparoscopic         HIF                        NMI                        Laparoscopic
                   insufflator * * *.                                                         insufflator and
                                                                                              accessories.
884.4530........  OB/GYN specialized   HFB                        NMG                        Gynecological
                   manual instrument.                                                         biopsy forceps.
886.4350........  Manual ophthalmic    HNN                        NLA                        Ophthalmic knife.
                   surgical
                   instrument.
----------------------------------------------------------------------------------------------------------------


[[Page 23142]]


  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 26,
                2004. Any new 510(k) will require validation data upon publication of this list.]
----------------------------------------------------------------------------------------------------------------
                                                                                               Product code name
   21 CFR section       Classification      Product code for non-       Product code for        for reprocessed
                             name            reprocessed device        reprocessed device           device
----------------------------------------------------------------------------------------------------------------
Unclassified........  Oocyte aspiration   MHK                       NMO                       Oocyte aspiration
                       needles.                                                                needles.
Unclassified........  Percutaneous        LIT                       NMM                       Transluminal
                       transluminal                                                            peripheral
                       angioplasty                                                             angioplasty
                       catheter                                                                catheter.
                       angioplasty
                       catheter.
Unclassified........  Ultrasonic          LFL                       NLQ                       Ultrasonic
                       surgical                                                                scalpel.
                       instrument.
868.5150............  Anesthesia          BSP                       NNH                       Anesthetic
                       conduction needle.                                                      conduction needle
                                                                                               (with or without
                                                                                               introducer).
868.5150............  Anesthesia          MIA                       NMR                       Short term spinal
                       conduction needle.                                                      needle.
868.5730............  Tracheal tube.....  BTR                       NMA                       Tracheal tube
                                                                                               (with or without
                                                                                               connector).
868.5905............  Non[chyph]con[chyp  BZD                       NMC                       Noncontinuous
                       h]tin[chyph]u[chy                                                       ventilator
                       ph]ous (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 catheter.                                                      oximeter
                                                                                               catheter.
870.1280............  Steerable catheter  DRA                       NKS                       Steerable
                                                                                               catheter.
870.1290............  Steerable catheter  DXX                       NKR                       Steerable 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) biopsy
                       rigid) and                                                              forceps.
                       accessories.
876.1075............  Gastro-Urology      FCG                       NMX                       G-U biopsy needle
                       biopsy instrument.                                                      and needle set.
876.1075............  Gastroenterology-   KNW                       NLS                       Biopsy instrument.
                       urology biopsy
                       instrument.
876.1500............  Endoscope and       FBK, FHP                  NMY                       Endoscopic needle.
                       accessories.
876.1500............  Endoscope and       MPA                       NKZ                       Endoilluminator.
                       accessories.
876.1500............  Endoscope and       GCJ                       NLM                       General and
                       accessories.                                                            plastic surgery
                                                                                               laparoscope.
876.1500............  Endoscope and       FHO                       NLX                       Spring-loaded
                       accessories.                                                            Pneumoperitoneum
                                                                                               Needle.
876.4300............  Endoscopic          FAS                       NLW                       Active urological
                       electrosurgical                                                         electrosurgical
                       unit and                                                                electrode.
                       accessories.
876.4300............  Endoscopic unit     FEH                       NLV                       Flexible suction
                       accessories.                                                            coagulator
                                                                                               electrode.
876.4300............  Endoscopic          KGE                       NLU                       Electric biopsy
                       electrosurgical                                                         forceps.
                       unit and
                       accessories.
876.4300............  Endoscopic          FDI                       NLT                       Flexible snare.
                       electrosurgical
                       unit and
                       accessories.
876.4300............  Endoscopic          KNS                       NLR                       Endoscopic (with
                       electrosurgical                                                         or without
                       unit and                                                                accessories)
                       accessories.                                                            Electrosurgical
                                                                                               unit.
876.5010............  Biliary catheter    FGE                       NML                       Biliary catheter.
                       and accessories.
876.5540............  Blood access        LBW                       NNF                       Single needle
                       device and                                                              dialysis set (co-
                       accessories.                                                            axial flow).
876.5540............  Blood access        FIE                       NNE                       Fistula needle.
                       device and
                       accessories.
876.5820............  Hemodialysis        FIF                       NNG                       Single needle
                       systems and                                                             dialysis set with
                       accessories.                                                            and accessories
                                                                                               uni-directional
                                                                                               pump.
878.4300............  Implantable clip..  FZP                       NMJ                       Implantable clip.
878.4750............  Implantable staple  GDW                       NLL                       Implantable
                                                                                               staple.
880.5570............  Hypodermic single   FMI                       NKK                       Hypodermic single
                       lumen needle.                                                           lumen needle.
880.5860............  Piston syringe....  FMF                       NKN                       Piston syringe.
882.4300............  Manual cranial      HBG                       NLO                       (Manual) drills,
                       drills, burrs,                                                          burrs, burrs,
                       trephines and                                                           trephines and
                       accessories.                                                            accessories.
882.4305............  Powered compound    HBF                       NLP                       (Powered,
                       cranial drills,                                                         compound) drills,
                       burrs, trephines                                                        burrs, trephines
                       . . ..                                                                  and accessories.
882.4310............  Powered simple      HBE                       NLN                       (Simple, powered)
                       cranial drills,                                                         drills, burrs,
                       burrs, trephines.                                                       trephines and
                                                                                               accessories.
884.1720............  Gynecologic         HET                       NMH                       Gynecologic
                       laparoscope and                                                         laparoscope (and
                       accessories.                                                            accessories).
884.6100............  Assisted            MQE                       NNB                       Assisted
                       reproduction                                                            reproduction
                       needle.                                                                 needle.
886.4370............  Keratome..........  HMY, HNO                  NKY                       Keratome blade.
886.4670............  Phacofragmentation  HQC                       NKX                       Phacoemulsificatio
                       system.                                                                 n needle.

[[Page 23143]]

 
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
  ``Guidance for Hemodialyzer Reuse Labeling'' (final draft issued on October 6, 1995).

III. Comments

    You may submit written or electronic comments on these lists to the 
Dockets Management Branch (see ADDRESSES). You may submit a single copy 
of an electronic comment to http://www.fda.gov/dockets/ecomments. You 
should submit two copies of any mailed comments but individuals may 
submit one 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 Dockets Management Branch between 9 
a.m. and 4 p.m., Monday through Friday.

                                   Attachment 1.--List of SUDs Known to be Reprocessed or Considered for Reprocessing
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                       Critical/semi-
            Medical specialty       Device type        Regulation No.         Class       Product code      Risk        critical/non-       Premarket
                                                                                                          1,2,3,3*        critical            exempt
--------------------------------------------------------------------------------------------------------------------------------------------------------
1........  Cardio.............  Cardiopulmonary     Unclassified                        MAB                       1  C                   N
                                 Bypass Marker.
2........  Cardio.............  Percutaneous &      post amendment        III           LOX                       3  C                   N
                                 Operative
                                 Transluminal
                                 Coronary
                                 Angioplasty
                                 Catheter (PCTA).
3........  Cardio.............  Percutaneous        Post                  III           LPB                       3  C                   N
                                 Ablation           amendment
                                 Electrode.
4........  Cardio.............  Peripheral          Unclassified                        LIT                       3  C                   N
                                 Transluminal
                                 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 Array  870.1220              II            MTD                       3  C                   N
                                 Catheter.
9........  Cardio.............  Fiberoptic          870.1230              II            DQE                       3  C                   N
                                 Oximeter Catheter.
10.......  Cardio.............  Steerable Catheter  870.1280              II            DRA                       3  C                   N
11.......  Cardio.............  Steerable Catheter  870.1290              II            DXX                       3  C                   N
                                 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 Saturation   870.2700              II            MUD                       3  C                   N
                                 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
                                 Stabilizer, Heart.
22.......  Cardio.............  External Vein       870.4885              II            DWQ                       3  C                   N
                                 Stripper.
23.......  Cardio.............  Compressible Limb   870.5800              II            JOW                       1  N                   N
                                 Sleeve.
24.......  Dental.............  Bur...............  872.3240              I             EJL                       1  C                   Y
25.......  Dental.............  Diamond Coated Bur  872.3240              I             EJL                       3  C                   Y
26.......  Dental.............  Diamond Instrument  872.4535              I             DZP                       3  C                   Y
27.......  Dental.............  AC-Powered Bone     872.4120              II            DZH                       2  C                   N
                                 Saw.
28.......  Dental.............  Manual Bone Drill   872.4120              II            DZJ                       2  C                   N
                                 and Wire Driver.
29.......  Dental.............  Powered Bone Drill  872.4120              II            DZI                       2  C                   N
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 Orthodontic   872.5410              I             EJF                       3  S                   Y
                                 Bracket.
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 Bur  874.4140              I             EQJ                       3  C                   Y
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 &
                                 General Use In
                                 Otolarngology.
38.......  ENT................  Microsurgical       874.4490              II            LXR                       1  S                   N
                                 Argon Fiber Optic
                                 Laser Cable, For
                                 Use In Otology.

[[Page 23144]]

 
39.......  ENT................  Microsurgical       874.4500              II            EWG                       1  S                   N
                                 Carbon-Dioxide
                                 Fiber Optic Laser
                                 Cable.
40.......  ENT................  Bronchoscope        874.4680              II            BWH                       3  S                   N
                                 Biopsy Forceps
                                 (Non-Rigid).
41.......  ENT................  Bronchoscope        874.4680              II            JEK                       1  S                   N
                                 Biopsy Forceps
                                 (Rigid).
42.......  Gastro/Urology.....  Biopsy Forceps      876.1075              I             FFF                       1  S                   Y
                                 Cover.
43.......  Gastro/Urology.....  Biopsy Instrument.  876.1075              II            KNW                       3  S                   N
44.......  Gastro/Urology.....  Biopsy Needle Set.  876.1075              II            FCG                       3  S                   N
45.......  Gastro/Urology.....  Biopsy Punch......  876.1075              II            FCI                       2  S                   N
46.......  Gastro/Urology.....  Mechanical Biopsy   876.1075              II            FCF                       2  S                   N
                                 Instrument.
47.......  Gastro/Urology.....  Non-Electric        876.1075              I             FCL                       3  S                   Y
                                 Biopsy Forceps.
48.......  Gastro/Urology.....  Cytology Brush For  876.1500              II            FDX                       2  S                   N
                                 Endoscope.
49.......  Gastro/Urology.....  Endoscope           876.1500              II            KOG                       2  S                   N
                                 Accessories.
50.......  Gastro/Urology.....  Extraction          876.1500              II            KOG                       2  S                   N
                                 Balloons/Baskets.
51.......  Gastro/Urology.....  Endoscopic Needle.  876.1500              II            FBK                       3  C                   N
52.......  Gastro/Urology.....  Simple              876.1500              II            FHP                       3  C                   N
                                 Pneumoperitoneum
                                 Needle.
53.......  Gastro/Urology.....  Spring Loaded       876.1500              II            FHO                       3  C                   N
                                 Pneumoperitoneum
                                 Needle.
54.......  Gastro/Urology.....  Active              876.4300              II            FAS                       3  S                   N
                                 Electrosurgical
                                 Electrode.
55.......  Gastro/Urology.....  Biliary             876.5010,             II            FGE                       3  S                   N
                                 Sphincterotomes.   876.1500
56.......  Gastro/Urology.....  Electric Biopsy     876.4300              II            KGE                       3  S                   N
                                 Forceps.
57.......  Gastro/Urology.....  Electrosurgical     876.4300              II            KNS                       3  S                   N
                                 Endoscopic Unit
                                 (With Or Without
                                 Accessories).
58.......  Gastro/Urology.....  Flexible Snare....  876.4300              II            FDI                       3  S                   N
59.......  Gastro/Urology.....  Flexible Suction    876.4300              II            FEH                       3  S                   N
                                 Coagulator
                                 Electrode.
60.......  Gastro/Urology.....  Flexible Stone      876.4680              II            FGO                       3  S                   Y
                                 Dislodger.
61.......  Gastro/Urology.....  Metal Stone         876.4680              II            FFL                       3  S                   Y
                                 Dislodger.
62.......  Gastro/Urology.....  Needle Holder.....  876.4730              I             FHQ                       1  C                   Y
63.......  Gastro/Urology.....  Non-Electrical      876.4730              I             FGX                       1  S                   Y
                                 Snare.
64.......  Gastro/Urology.....  Urological          876.5130              II            KOD                       2  S                   N
                                 Catheter.
65.......  Gastro/Urology.....  Single Needle       876.5540              II            LBW, FIE                  3  C                   N
                                 Dialysis Set.
66.......  Gastro/Urology.....  Hemodialysis Blood  876.5820              II            KOC                       2  S                   N
                                 Circuit
                                 Accessories.
67.......  Gastro/Urology.....  Single Needle       876.5820              II            FIF                       3  C                   N
                                 Dialysis Set.
68.......  GE/U...............  Hemorrhoidal        876.4400              II            FHN                       2  C                   N
                                 Ligator.
69.......  General............  Implanted,          Post-amendment        III           LKK                       3  C                   N
           Hospital...........   Programmable
                                 Infusion Pump.
70.......  General............  Needle Destruction  Post-amendment        III           MTV                       1  N                   N
           Hospital...........   Device.
71.......  General............  Non-Powered         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.

[[Page 23145]]

 
74.......  General............  Temperature         880.5560              I             FOH                       2  N                   Y
           Hospital...........   Regulated Water
                                 Mattress.
75.......  General............  Hypodermic Single   880.5570              II            FMI                       3  C                   N
           Hospital...........   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 Medical  880.6820              I             JOK                       1  N                   Y
           Hospital...........   Scissors.
79.......  General............  Irrigating Syringe  880.6960              I             KYZ,                      1  C                   Y
           Hospital...........                                                          KYY
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 &
                                 Accessories
                                 (Manual).
84.......  Neuro..............  Drills, Burrs,      882.4305              II            HBF                      3*  C                   N
                                 Trephines &
                                 Accessories
                                 (Compound,
                                 Powered).
85.......  Neuro..............  Drills, Burrs,      882.4310              II            HBE                      3*  C                   N
                                 Trephines &
                                 Accessories
                                 (Simple, Powered).
86.......  OB/GYN.............  Oocyte aspiration   Unclassified          II            MHK                       3  C                   N
                                 needle.
87.......  OB/GYN.............  Laparoscope         884.1720              I             HET                       2  C                   Y
                                 Accessories.
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 Bipolar  884.4150              II            HIN                       2  N                   N
                                 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 Scissors  884.4520              I             HDJ                       1  C                   Y
103......  OB/GYN.............  Biopsy Forceps....  884.4530              I             HFB                       3  C                   Y
104......  OB/GYN.............  Assisted            884.6100              II            MQE                       3  C                   N
                                 reproduction
                                 needle.
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              Inot exempt   HMY,                      3  C                   N
                                                                                        HNO
109......  Ophthalmic.........  Phacoemulsificatio  886.4670              II            HQC                       3  C                   N
                                 n Needle.
110......  Ophthalmic.........  Phacoemulsificatio  886.4670              II            MUS                       2  C                   N
                                 n/
                                 Phacofragmentatio
                                 n Fluidic.
111......  Ophthalmic.........  Phacofragmentation  886.4670              II            HQC                       1  N                   N
                                 Unit.
112......  Ortho..............  Saw Blades........  878.4820              I             GFA,                      1  C                   Y
                                                                                        DWH,
                                                                                        GEY,
                                                                                        GET
113......  Ortho..............  Surgical Drills...  878.4820              I             GEY,                      1  C                   Y
                                                                                        GET
114......  Ortho..............  Arthroscope         888.1100              II            HRX                       2  C                   Y
                                 accessories.
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

[[Page 23146]]

 
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,                      1  C                   Y
                                 Drills.            878.4820                            HRG
129......  Ortho..............  External Fixation   888.3040              II            JEC                       2  N                   N
                                 Frame.             888.3030                            KTW
                                                                                        KTT
130......  Physical...........  Non-Heating Lamp    Unclassified          ............  NHN                       1  N                   N
           Medicine...........   for Adjunctive
                                 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,                      2  C                   Y
           Surgery............                                                          GEF,
                                                                                        FHM,
                                                                                        HBT
137......  Radiology..........  Isotope Needle....  892.5730              II            IWF                       3  C                   N
138......  Resp...............  Endotracheal Tube   Unclassified          III           LNZ                       3  C                   N
                                 Changer.
139......  Resp...............  Anesthesia          868.5150              II            BSP                       3  C                   N
                                 conduction needle.
140......  Resp...............  Short term spinal   868.5150              II            MIA                       3  C                   N
                                 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.
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          Unclassified                        HWE                       2  C                   N
                                 Orthopedic
                                 Instrument and
                                 accessories.
151......  Surgery............  Breast Implant      Unclassified                        MRD                       1  C                   N
                                 Mammary Sizer.
152......  Surgery............  Ultrasonic          Unclassified                        LFL                       3  C                   N
                                 Surgical
                                 Instrument.
153......  Surgery............  Trocar............  874.4420              I             KAB,                      3  C                   Y
                                                                                        KBG,
                                                                                        KCI
154......  Surgery............  Endoscopic Blades.  876.1500              II            GCP,                      2  C                   N
                                                                                        GCR
155......  Surgery............  Endoscopic          876.1500              II            GCP,                      1  C                   N
                                 Guidewires.                                            GCR
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 &
                                 Coagulation
                                 Device &
                                 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.

[[Page 23147]]

 
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
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 Instrument.  878.4800              I             MDM,                      1  C                   Y
                                                                                        MDW
185......  Surgery............  Manual Retractor..  878.4800              I             GZW                       1  C                   Y
186......  Surgery............  Manual Saw And      878.4800              I             GDR                       1  C                   Y
                                 Accessories.                                           HAC
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 Cutting  878.4800              I             HTZ                       1  C                   Y
                                 Instrument.
191......  Surgery............  Orthopedic Spatula  878.4800              I             HXR                       1  C                   Y
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.
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,                      1  C                   Y
                                                                                        GEY
213......  Surgery............  Cardiovascular      878.4820              I             DWH                       1  C                   Y
                                 Surgical Saw
                                 Blade.
214......  Surgery............  Chisel (Osteotome)  878.4820              I             KDG                       1  C                   Y
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 Powered   878.4820              I             GET                       2  C                   Y
                                 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............  Enodoscopic         888.4540              I             HXJ                       2  C                   Y
                                 Staplers.
224......  Surgery............  Trocar............  876.1500              II            GCJ,                      3  C                   N
                                                    870.1390                            DRC
225......  Surgery............  Surgical Cutting    878.4800,             I             GDZ,                      2  C                   Y
                                 Accessories.       874.4420                            GDX,
                                                                                        GES,
                                                                                        KBQ,
                                                                                        KAS
226......  Surgery............  Electrosurgical     876.4300              II            HAM,                      2  C                   N
                                 Electrodes/        878.4400                            GEI,
                                 Handles/Pencils.                                       FAS

[[Page 23148]]

 
227......  Surgery............  Scissor Tips......  878.4800,             I             LRW,                      2  C                   Y
                                                    884.4520,                           HDK,
                                                    874.4420                            HDJ,
                                                                                        JZB,
                                                                                        KBD
228......  Surgery............  Laser Fiber         878.4810              II            GEX                       1  C                   N
                                 Delivery Systems.  874.4500                            EWG
                                                    886.4390                            LLW
                                                    884.4550                            HQF
                                                    886.4690                            HHR
                                                                                        HQB
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 = low risk according to RPS
2 = moderate risk according to RPS
3 = high risk according to RPS
3* = high risk due to neurological use


    Dated: April 23, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-10413 Filed 4-23-03; 5:03 pm]
BILLING CODE 4160-01-P