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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 November 29, 2021

This page lists devices currently eligible for third-party review under the FDA's 510(k) Third Party Review Program, formally, the Accredited Persons Program. Premarket Notifications ["510(k)'s"] for devices on this list can be submitted to FDA-recognized 3P510K Review Organizations (Accredited Persons) in lieu of FDA. Information on the 510(k) Third Party Review Program, including links to this page and to a list of accredited persons, is available at the 510(k) Third Party Review Program website.

How to use the list of eligible devices

The list has four 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 provides a link to available standards to assist manufacturers in the preparation-and 3P510k review organizations in the review-of 510(k)s for eligible devices.

Some important exceptions to the list

Please see the 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations for exceptions to the list.


Neurology

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Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
882.1030 Ataxiagraph. I  
  PTB -  Ataxiagraph With Interpretive Software  
882.1240 Echoencephalograph. II  
  GXW -  Echoencephalograph  
882.1275 Electroconductive media. II  
  GYB -  Media, Electroconductive  
882.1310 Cortical electrode. II  
  GYC -  Electrode, Cortical  
882.1320 Cutaneous electrode. II  
  GXY -  Electrode, Cutaneous  
882.1330 Depth electrode. II  
  GZL -  Electrode, Depth  
882.1340 Nasopharyngeal electrode. II  
  GZK -  Electrode, Nasopharyngeal  
882.1350 Needle electrode. II  
  GXZ -  Electrode, Needle  
882.1400 Electroencephalograph. II  
  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  
  GWS -  Analyzer, Spectrum, Electroencephalogram Signal  
882.1460 Nystagmograph. II  
  GWN -  Nystagmograph  
882.1550 Nerve conduction velocity measurement device. II  
  JXE -  Device, Nerve Conduction Velocity Measurement  
882.1570 Powered direct-contact temperature measurement device. II  
  HCS -  Device, Temperature Measurement, Direct Contact, Powered  
882.1610 Alpha monitor. II  
  GXS -  Monitor, Alpha  
882.1620 Intracranial pressure monitoring device. II  
  GWM -  Device, Monitoring, Intracranial Pressure  
882.1630 Cranial motion measurement device. II  
  POP -  Cranial Motion Measurement Device  
882.1835 Physiological signal amplifier. II  
  GWL -  Amplifier, Physiological Signal  
882.1845 Physiological signal conditioner. II  
  GWK -  Conditioner, Signal, Physiological  
882.1870 Evoked response electrical stimulator. II  
  GWF -  Stimulator, Electrical, Evoked Response  
  NTU -  Evoked Potential Stimulator, Thermal  
882.1880 Evoked response mechanical stimulator. II  
  GZP -  Stimulator, Mechanical, Evoked Response  
882.1890 Evoked response photic stimulator. II  
  GWE -  Stimulator, Photic, Evoked Response  
882.1900 Evoked response auditory stimulator. II  
  GWJ -  Stimulator, Auditory, Evoked Response  
882.1950 Tremor transducer. II  
  GYD -  Transducer, Tremor  
882.4100 Ventricular catheter. II  
  HCA -  Catheter, Ventricular  
882.4150 Scalp clip. II  
  HBO -  Clip, Scalp  
882.4175 Aneurysm clip applier. II  
  HCI -  Applier, Aneurysm Clip  
882.4190 Clip forming/cutting instrument. I  
  NMN -  Instrument, Clip, Forming/Cutting, Reprocessed  
882.4250 Cryogenic surgical device. II  
  GXH -  Device, Surgical, Cryogenic  
882.4275 Dowel cutting instrument. II  
  GZQ -  Instrument, Dowel Cutting  
882.4300 Manual cranial drills, burrs, trephines, and their accessories II  
  HBG -  Drills, Burrs, Trephines & Accessories (Manual)  
  NLO -  Drills, Burrs, Trephines And Accessories (Manual), Reprocessed  
882.4305 Powered compound cranial drills, burrs, trephines, and their accessories. II  
  HBF -  Drills, Burrs, Trephines & Accessories (Compound, Powered)  
  NLP -  Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed  
882.4310 Powered simple cranial drills, burrs, trephines, and their accessories. II  
  HBE -  Drills, Burrs, Trephines & Accessories (Simple, Powered)  
  NLN -  Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed  
882.4360 Electric cranial drill motor. II  
  HBC -  Motor, Drill, Electric  
882.4370 Pneumatic cranial drill motor. II  
  HBB -  Motor, Drill, Pneumatic  
882.4400 Radiofrequency lesion generator. II  
  GXD -  Generator, Lesion, Radiofrequency  
882.4460 Neurosurgical head holder (skull clamp). II  
  HBL -  Holder, Head, Neurosurgical (Skull Clamp)  
882.4700 Neurosurgical paddie. II  
  HBA -  Neurosurgical Paddie  
882.4725 Radiofrequency lesion probe. II  
  GXI -  Probe, Radiofrequency Lesion  
882.4800 Self-retaining retractor for neurosurgery. II  
  GZT -  Retractor, Self-Retaining, For Neurosurgery  
882.4840 Manual rongeur. II  
  HAE -  Rongeur, Manual  
882.4845 Powered rongeur. II  
  HAD -  Rongeur, Powered  
882.5070 Bite block. II  
  JXL -  Block, Bite  
882.5235 Aversive conditioning device. II  
  HCB -  Device, Aversive Conditioning  
882.5500 Lesion temperature monitor. II  
  GXT -  Monitor, Lesion Temperature  
882.5810 External functional neuromuscular stimulator. II  
  GZI -  Stimulator, Neuromuscular, External Functional  
882.5890 Transcutaneous electrical nerve stimulator for pain relief. II  
  GZJ -  Stimulator, Nerve, Transcutaneous, For Pain Relief  
  LIH -  Interferential Current Therapy  
  NFO -  Stimulator, Transcutaneous Electrical, Aesthetic Purposes  
  NHI -  Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief  
  NUH -  Stimulator, Nerve, Transcutaneous, Over-The-Counter  
  NYN -  Stimulator, Electrical, Transcutaneous, For Arthritis  
  NYW -  Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief  
  NYX -  Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes  
  OCF -  Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief  
882.5960 Skull tongs for traction. II  
  HAX -  Tong, Skull For Traction  

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