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U.S. Department of Health and Human Services

List of Devices for Third Party Review

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Database updated: February 7, 2002

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This page lists devices currently eligible for third-party review under the FDA's Accredited Persons Program. Premarket notifications ["510(k)'s"] for devices on this list can be submitted to FDA-accredited third parties (Accredited Persons) in lieu of FDA. Information on the Accredited Persons Program, including links to this page and to a list of Accredited Persons, is available at the Accredited Persons Inspection Program website.

The following topics are discussed in this introduction to the list of eligible devices:

  • How to use the list of eligible devices
  • Some important exceptions to the list
  • Expansion pilot

How to Use the List of Eligible Devices

The list has five columns:

  • The first column provides the classification regulation number for each device from Title 21, Code of Federal Regulations (CFR), Parts 862-892. A classification regulation identifies a generic type of device and specifies the regulatory class that FDA has assigned to the device.
  • The second and third columns show the classification name for the device from the CFR, and the class of the device, respectively. In the second column, under each classification regulation name, one or more 3-letter product codes appear, along with the device name associated with each product code. Product codes represent specific subsets of devices grouped under the same classification regulation name. Manufacturers should determine the classification of their device at the product code level that most appropriately identifies their device(s).
  • The fourth column indicates if a device (product code) is included in the expansion pilot, described below, by showing the word "pilot." If this column is blank, the device is eligible for review under the pre-existing program and is not part of the expansion pilot.
  • The fifth column provides a link to device-specific guidance, if available, or to general guidance to assist manufacturers in the preparation-and Accredited Persons in the review-of 510(k)'s for eligible devices. Links are not provided for devices in the expansion pilot; device-specific guidance does not exist for these devices, and special procedures apply to the review of 510(k)'s for these devices by Accredited Persons, as discussed in FDA's January 2001 procedural guidance for the Accredited Persons Program, cited below.
Some Important Exceptions to the List

There are some exceptions that are not reflected in the eligible device list:

  • A device may be eligible even if it does not appear on the list if it is a Class I or Class II device that has been exempted from 510(k) by regulation, but requires a 510(k) because it exceeds the limitations of the exemption (as discussed in FDA's device classification regulations). Devices that are exempt from 510(k) are not shown on the list.
  • A Class II device on the list is ineligible if a 510(k) for the device requires clinical data to demonstrate substantial equivalence. This exception is discussed in FDA's procedural guidance for the Accredited Persons Program, cited below.
  • A device on the list is ineligible if a 510(k) for the device requires multi-Center review (e.g., 510(k)'s for drug/device combination products) or if a Center other than CDRH (e.g., the Center for Biologics Evaluation and Research) has primary responsibility for review.
Expansion Pilot

In an effort to encourage greater use of the Accredited Persons Program, FDA expanded the third party pilot to permit Accredited Persons to review many Class II devices that were not previously eligible. The expanded pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. Information on the expansion pilot, including criteria allowing for the review of these Class II devices, can be found in the guidance document entitled Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties. Accredited Persons and other interested parties should refer to Section II.B., Purpose and Nature of the Program, for the criteria that would allow for the review of the Class II devices in the expansion pilot.


Neurology

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Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
882.1020 RIGIDITY ANALYZER II  
  GZM -  Analyzer, Rigidity   Pilot  
882.1030 ATAXIAGRAPH I  
 General Guidance
  GWW -  Ataxiagraph      
882.1240 ECHOENCEPHALOGRAPH II  
  GXW -  Echoencephalograph      
882.1275 ELECTROCONDUCTIVE MEDIA II  
  GYB -  Media, Electroconductive   Pilot  
882.1310 CORTICAL ELECTRODE II  
Guidance Withdrawn
  GYC -  Electrode, Cortical      
882.1320 CUTANEOUS ELECTRODE II  
  GXY -  Electrode, Cutaneous   Pilot  
882.1330 DEPTH ELECTRODES II  
  GZL -  Electrode, Depth   Pilot  
882.1340 NASOPHARYNGEAL ELECTRODE II  
  GZK -  Electrode, Nasopharyngeal   Pilot  
882.1350 NEEDLE ELECTRODE II  
  GXZ -  Electrode, Needle   Pilot  
882.1400 ELECTROENCEPHALOGRAPH II  
Guidance Withdrawn
  GWQ -  Full-Montage Standard Electroencephalograph      
  OLT -  Non-Normalizing Quantitative Electroencephalograph Software      
  OLU -  Normalizing Quantitative Electroencephalograph Software      
  OLV -  Standard Polysomnograph With Electroencephalograph      
  OLX -  Source Localization Software For Electroencephalograph Or Magnetoencephalograph      
  OLY -  Magnetoencephalograph      
  OMA -  Amplitude-Integrated Electroencephalograph      
  OMC -  Reduced- Montage Standard Electroencephalograph      
882.1420 ELECTROENCEPHALOGRAM (EEG) SIGNAL SPECTRUM ANALYZER I  
 General Guidance
  GWS -  Analyzer, Spectrum, Electroencephalogram Signal      
882.1460 NYSTAGMOGRAPH II  
  GWN -  Nystagmograph   Pilot  
882.1480 NEUROLOGICAL ENDOSCOPE II  
Guidance Withdrawn
  GWG -  Endoscope, Neurological      
882.1540 GALVANIC SKIN RESPONSE MEASUREMENT DEVICE II  
  GZO -  Device, Galvanic Skin Response Measurement   Pilot  
882.1550 NERVE CONDUCTION VELOCITY MEASUREMENT DEVICE II  
  JXE -  Device, Nerve Conduction Velocity Measurement   Pilot  
882.1560 SKIN POTENTIAL MEASUREMENT DEVICE II  
  HCJ -  Device, Skin Potential Measurement   Pilot  
882.1570 POWERED DIRECT CONTACT TEMPERATURE MEASUREMENT DEVICE II  
  HCS -  Device, Temperature Measurement, Direct Contact, Powered   Pilot  
882.1610 ALPHA MONITOR II  
  GXS -  Monitor, Alpha   Pilot  
882.1620 INTRACRANIAL PRESSURE MONITORING DEVICE II  
  GWM -  Device, Monitoring, Intracranial Pressure   Pilot  
882.1835 PHYSIOLOGICAL SIGNAL AMPLIFIER II  
  GWL -  Amplifier, Physiological Signal   Pilot  
882.1845 PHYSIOLOGICAL SIGNAL CONDITIONER II  
  GWK -  Conditioner, Signal, Physiological   Pilot  
882.1855 ELECTROENCEPLELOGRAM (EEG) TELEMETRY SYSTEM II  
  GYE -  Encephalogram Telemetry System   Pilot  
882.1870 EVOKED RESPONSE ELECTRICAL STIMULATOR II  
  GWF -  Stimulator, Electrical, Evoked Response   Pilot  
  NTU -  Evoked Potential Stimulator, Thermal   Pilot  
882.1880 EVOKED RESPONSE MECHANICAL STIMULATOR II  
  GZP -  Stimulator, Mechanical, Evoked Response   Pilot  
882.1890 EVOKED RESPONSE PHOTIC STIMULATOR II  
  GWE -  Stimulator, Photic, Evoked Response   Pilot  
882.1900 EVOKED RESPONSE AUDITORY STIMULATOR II  
  GWJ -  Stimulator, Auditory, Evoked Response   Pilot  
882.1950 TREMOR TRANSDUCER II  
  GYD -  Transducer, Tremor   Pilot  
882.4060 VENTRICULAR CANNULA I  
 General Guidance
  HCD -  Cannula, Ventricular      
882.4100 VENTRICULAR CATHETER II  
  HCA -  Catheter, Ventricular   Pilot  
882.4150 SCALP CLIP II  
  HBO -  Clip, Scalp   Pilot  
882.4175 ANEURYSM CLIP APPLIER II  
  HCI -  Applier, Aneurysm Clip   Pilot  
882.4250 CRYOGENIC SURGICAL DEVICE II  
  GXH -  Device, Surgical, Cryogenic   Pilot  
882.4275 DOWEL CUTTING INSTRUMENT II  
  GZQ -  Instrument, Dowel Cutting   Pilot  
882.4300 MANUAL CRANIAL DRILLS, BURRS, TREPHINES & ACCESSORIES II  
  HBG -  Drills, Burrs, Trephines & Accessories (Manual)   Pilot  
882.4305 POWERED COMPOUND CRANIAL DRILLS, BURRS, TREPHINES & ACCESSORIES II  
  HBF -  Drills, Burrs, Trephines & Accessories (Compound, Powered)   Pilot  
882.4310 POWERED SIMPLE CRANIAL DRILLS, BURRS, TREPHINES & ACCESSORIES II  
  HBE -  Drills, Burrs, Trephines & Accessories (Simple, Powered)   Pilot  
882.4360 ELECTRIC CRANIAL DRILL MOTOR II  
  HBC -  Motor, Drill, Electric   Pilot  
882.4370 PNEUMATIC CRANIAL DRILL MOTOR II  
  HBB -  Motor, Drill, Pneumatic   Pilot  
882.4400 RADIOFREQUENCY LESION GENERATOR II  
  GXD -  Generator, Lesion, Radiofrequency   Pilot  
882.4460 NEUROSURGICAL HEAD HOLDER (SKULL CLAMP) II  
  HBL -  Holder, Head, Neurosurgical (Skull Clamp)   Pilot  
882.4545 SHUNT SYSTEM IMPLANTATION INSTRUMENT I  
 General Guidance
  GYK -  Instrument, Shunt System Implantation      
882.4560 STEREOTAXIC INSTRUMENT II  
 
  HAW -  Neurological Stereotaxic Instrument   Pilot  
  ONN -  Intraoperative Orthopedic Joint Assessment Aid      
882.4700 COTTONOID PADDIE II  
  HBA -  Neurosurgical Paddie   Pilot  
882.4725 RADIOFREQUENCY LESION PROBE II  
  GXI -  Probe, Radiofrequency Lesion   Pilot  
882.4800 SELF-RETAINING RETRACTOR FOR NEUROSURGERY II  
  GZT -  Retractor, Self-Retaining, For Neurosurgery   Pilot  
882.4840 MANUAL RONGEUR II  
  HAE -  Rongeur, Manual   Pilot  
882.4845 POWERED RONGEUR II  
  HAD -  Rongeur, Powered   Pilot  
882.5070 BITE BLOCK II  
  JXL -  Block, Bite   Pilot  
882.5235 AVERSIVE CONDITIONING DEVICE II  
  HCB -  Device, Aversive Conditioning   Pilot  
882.5500 LESION TEMPERATURE MONITOR II  
  GXT -  Monitor, Lesion Temperature   Pilot  
882.5550 CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS II  
  JXG -  Shunt, Central Nervous System And Components   Pilot  
882.5810 EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR II  
  GZI -  Stimulator, Neuromuscular, External Functional   Pilot  
882.5890 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN RELIEF II  
Guidance Withdrawn
  GZJ -  Stimulator, Nerve, Transcutaneous, For Pain Relief      
  NHI -  Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief   Pilot  
  NYX -  Stimulator, Electrical, Transcutaneous, With Limted Output, For Aesthetic Purposes      
882.5960 SKULL TONG FOR TRACTION II  
  HAX -  Tong, Skull For Traction   Pilot  

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