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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 April 29, 2024

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.


General & Plastic Surgery
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Section No. Regulation Name
Product Code-Device Name		 Class
Available
Standards
878.4040 Surgical apparel.    
  FXX -  Mask, Surgical II
  FXY -  Hood, Surgical II
  FYB -  Gown, Patient II
878.4200 Introduction/drainage catheter and accessories.    
  NMT -  Needle, Catheter, Reprocessed I
878.4350 Cryosurgical unit and accessories.    
  FAZ -  System, Cryosurgical, Liquid Nitrogen, For Urology II
  GEH -  Unit, Cryosurgical, Accessories II
  ORE -  Cryogenic, Skin Tag Removal, Otc II
878.4370 Surgical drape and drape accessories.    
  PEM -  Dental Barriers And Sleeves II
  KKX -  Drape, Surgical II
  MMP -  Cover, Barrier, Protective II
878.4371 Irrigating wound retractor device.    
  PQI -  Wound Retraction And Protection System II
878.4400 Electrosurgical cutting and coagulation device and accessories.    
  OCL -  Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue II
  BWA -  Unit, Electrosurgical And Coagulation, With Accessories II
  DWG -  Electrosurgical Device II
  GEI -  Electrosurgical, Cutting & Coagulation & Accessories II
  HAM -  Apparatus, Electrosurgical II
  JOS -  Electrode, Electrosurgical II
  JOT -  Electrode, Gel, Electrosurgical II
  MUL -  Generator, Electrosurgical, Coagulation, Cancer II
  NEY -  System, Ablation, Microwave And Accessories II
  NTB -  System, Ablation, Ultrasound And Accessories II
  OAB -  Low Energy Direct Current Thermal Ablation System II
  ODR -  Electrosurgical Patient Return Electrode II
  ONQ -  Electrosurgical Coagulation For Aesthetic II
  OUB -  Instrument For Treatment Of Hyperhidrosis II
  PBX -  Massager, Vacuum, Radio Frequency Induced Heat II
  PDG -  Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator. II
878.4410 Low energy ultrasound wound cleaner.    
  NRB -  Wound Cleaner, Ultrasound II
  NRJ -  Ultrasound, Skin Permeation II
878.4460 Non-powdered surgeon's glove.    
  KGO -  Surgeon'S Gloves I
878.4580 Surgical lamp.    
  FST -  Light, Surgical, Fiberoptic II
  FTF -  Illuminator, Non-Remote II
  HBI -  Illuminator, Fiberoptic, Surgical Field II
  HJE -  Lamp, Fluorescein, Ac-Powered II
  PSN -  Light Based Imaging II
878.4630 Ultraviolet lamp for dermatologic disorders.    
  FTC -  Light, Ultraviolet, Dermatological II
  KGL -  Cabinet, Phototherapy (Puva) II
  MXG -  Lamp, Uvc, (For Treating Skin And Wounds) II
878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.    
  LEJ -  Booth, Sun Tan II
  RAB -  Sunlamp Products (Pre-Standard) II
  REF -  Suntan Bed II
  REG -  Suntan Lamp II
  REH -  Tabletop Sunlamp System II
878.4780 Powered suction pump.    
  BTA -  Pump, Portable, Aspiration (Manual Or Powered) II
  JCX -  Apparatus, Suction, Ward Use, Portable, Ac-Powered II
  OTK -  Wound Drain Catheter System II
878.4800 Manual surgical instrument for general use.    
  PIR -  Mercy Tape 2d And 3d Models I
  FSH -  Tray, Surgical, Needle I
  LXZ -  Guard, Instrument I
  NLK -  Needle, Biopsy, Cardiovascular, Reprocessed I
  NMU -  Needle, Gastro-Urology, Reprocessed I
  NNA -  Biopsy Device, Percutaneous, Reprocessed I
  NNC -  Needle, Aspiration And Needle, Reprocessed I
878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.    
  NVK -  Laser, Dental, Soft Tissue II
  LNK -  Laser For Gastro-Urology Use II
  GEX -  Powered Laser Surgical Instrument II
  NUV -  Massager, Vacuum, Light Induced Heating II
  ONE -  Powered Light Based Non-Laser Surgical Instrument II
  ONF -  Powered Light Based Non-Laser Surgical Instrument With Thermal Effect II
  ONG -  Powered Laser Surgical Instrument With Microbeam\Fractional Output II
  OYW -  Laser, Cellulite Appearance II
878.5070 Air-handling apparatus for a surgical operating room.    
  FLJ -  Unit, Airflow, Laminar II
  FRT -  Unit, Isolation, Surgical II
  FYD -  Apparatus, Exhaust, Surgical II
  ORC -  Air Filter Portable Apparatus II
878.5400 Low level laser system for aesthetic use    
  OLI -  Fat Reducing Low Level Laser II

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