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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.


General & Plastic Surgery

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Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
878.4040 Surgical apparel. II  
  FXX -  Mask, Surgical  
  FXY -  Hood, Surgical  
  FYB -  Gown, Patient  
878.4200 Introduction/drainage catheter and accessories. I  
  NMT -  Needle, Catheter, Reprocessed  
878.4350 Cryosurgical unit and accessories. II  
  FAZ -  System, Cryosurgical, Liquid Nitrogen, For Urology  
  GEH -  Unit, Cryosurgical, Accessories  
  ORE -  Cryogenic, Skin Tag Removal, Otc  
878.4370 Surgical drape and drape accessories. II  
  PEM -  Dental Barriers And Sleeves  
  KKX -  Drape, Surgical  
  MMP -  Cover, Barrier, Protective  
878.4371 Irrigating wound retractor device. II  
  PQI -  Wound Retraction And Protection System  
878.4400 Electrosurgical cutting and coagulation device and accessories. II  
  OCL -  Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue  
  BWA -  Unit, Electrosurgical And Coagulation, With Accessories  
  DWG -  Electrosurgical Device  
  GEI -  Electrosurgical, Cutting & Coagulation & Accessories  
  HAM -  Apparatus, Electrosurgical  
  JOS -  Electrode, Electrosurgical  
  JOT -  Electrode, Gel, Electrosurgical  
  MUL -  Generator, Electrosurgical, Coagulation, Cancer  
  NEY -  System, Ablation, Microwave And Accessories  
  NTB -  System, Ablation, Ultrasound And Accessories  
  OAB -  Low Energy Direct Current Thermal Ablation System  
  ODR -  Electrosurgical Patient Return Electrode  
  ONQ -  Electrosurgical Coagulation For Aesthetic  
  OUB -  Instrument For Treatment Of Hyperhidrosis  
  PBX -  Massager, Vacuum, Radio Frequency Induced Heat  
  PDG -  Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.  
878.4410 Low energy ultrasound wound cleaner. II  
  NRB -  Wound Cleaner, Ultrasound  
  NRJ -  Ultrasound, Skin Permeation  
878.4460 Non-powdered surgeon's glove. I  
  KGO -  Surgeon'S Gloves  
  OPA -  Powder-Free Non-Natural Rubber Latex Surgeon'S Gloves  
878.4580 Surgical lamp. II  
  FST -  Light, Surgical, Fiberoptic  
  FTF -  Illuminator, Non-Remote  
  HBI -  Illuminator, Fiberoptic, Surgical Field  
  HJE -  Lamp, Fluorescein, Ac-Powered  
  PSN -  Light Based Imaging  
878.4630 Ultraviolet lamp for dermatologic disorders. II  
  FTC -  Light, Ultraviolet, Dermatological  
  KGL -  Cabinet, Phototherapy (Puva)  
  MXG -  Lamp, Uvc, (For Treating Skin And Wounds)  
878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products. II  
  LEJ -  Booth, Sun Tan  
  RAB -  Sunlamp Products (Pre-Standard)  
  REF -  Suntan Bed  
  REG -  Suntan Lamp  
  REH -  Tabletop Sunlamp System  
878.4780 Powered suction pump. II  
  BTA -  Pump, Portable, Aspiration (Manual Or Powered)  
  JCX -  Apparatus, Suction, Ward Use, Portable, Ac-Powered  
  OTK -  Wound Drain Catheter System  
878.4800 Manual surgical instrument for general use. I  
  PIR -  Mercy Tape 2d And 3d Models  
  FSH -  Tray, Surgical, Needle  
  LXZ -  Guard, Instrument  
  NLK -  Needle, Biopsy, Cardiovascular, Reprocessed  
  NMU -  Needle, Gastro-Urology, Reprocessed  
  NNA -  Biopsy Device, Percutaneous, Reprocessed  
  NNC -  Needle, Aspiration And Needle, Reprocessed  
878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology. II  
  NVK -  Laser, Dental, Soft Tissue  
  LNK -  Laser For Gastro-Urology Use  
  GEX -  Powered Laser Surgical Instrument  
  NUV -  Massager, Vacuum, Light Induced Heating  
  ONE -  Powered Light Based Non-Laser Surgical Instrument  
  ONF -  Powered Light Based Non-Laser Surgical Instrument With Thermal Effect  
  ONG -  Powered Laser Surgical Instrument With Microbeam\Fractional Output  
  OYW -  Laser, Cellulite Appearance  
878.5040 Suction lipoplasty system. II  
  MUU -  System, Suction, Lipoplasty  
878.5070 Air-handling apparatus for a surgical operating room. II  
  FLJ -  Unit, Airflow, Laminar  
  FRT -  Unit, Isolation, Surgical  
  FYD -  Apparatus, Exhaust, Surgical  
  ORC -  Air Filter Portable Apparatus  
878.5400 Low level laser system for aesthetic use II  
  OLI -  Fat Reducing Low Level Laser  

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