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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 June 17, 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.


Gastroenterology

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Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
876.1075 Gastroenterology-urology biopsy instrument.    
  FCF -  Instrument, Biopsy, Mechanical, Gastrointestinal II
  FCG -  Biopsy Needle II
  FCI -  Punch, Biopsy II
  FCK -  Instrument, Biopsy, Suction II
  NLS -  Instrument, Biopsy, Reprocessed II
  NMX -  Needle And Needle Set, Gastro-Urology, Reprocessed II
  NON -  Forceps, Biopsy, Non-Electric, Reprocessed I
  KNW -  Instrument, Biopsy II
876.1500 Endoscope and accessories.    
  FBK -  Endoscopic Injection Needle, Gastroenterology-Urology II
  FCX -  Insufflator, Automatic Carbon-Dioxide For Endoscope II
  FDX -  Endoscopic Cytology Brush II
  FFS -  Image, Illumination, Fiberoptic, For Endoscope II
  FHO -  Pneumoperitoneum Needle II
  FHP -  Needle, Pneumoperitoneum, Simple II
  FHX -  Jelly, Lubricating, For Transurethral Surgical Instrument II
  FTI -  Lamp, Endoscope, Incandescent II
  OCT -  Anti Fog Solution And Accessories, Endoscopy II
  OCZ -  Endoscopic Grasping/Cutting Instrument, Non-Powered II
  KYH -  Endoscope, Ophthalmic II
  MPA -  Endoilluminator II
  GCI -  Laryngoscope, Endoscope II
876.1725 Gastrointestinal motility monitoring system.    
  FES -  Recorder, External, Pressure, Amplifier & Transducer II
  FFX -  System, Gastrointestinal Motility (Electrical) II
  KLA -  Monitor, Esophageal Motility, Anorectal Motility, And Tube II
876.4300 Endoscopic electrosurgical unit and accessories.    
  FAS -  Electrode, Electrosurgical, Active, Urological II
  FDI -  Snare, Flexible II
  FEH -  Electrode, Flexible Suction Coagulator II
  FFI -  System, Alarm, Electrosurgical II
  FHY -  Jelly, Contact, For Transurethral Surgical Instrument II
  KGE -  Forceps, Biopsy, Electric II
  KNS -  Unit, Electrosurgical, Endoscopic (With Or Without Accessories) II
876.4480 Electrohydraulic lithotriptor.    
  FEO -  Lithotriptor, Ultrasonic II
  FFK -  Lithotriptor, Electro-Hydraulic II
876.4500 Mechanical lithotriptor.    
  FGK -  Tripsor, Stone, Bladder II
876.4620 Ureteral stent.    
  FAD -  Stent, Ureteral II
876.4680 Ureteral stone dislodger.    
  NQV -  Catheter, Suction, Tracheobronchial, Reprocessed I
  NQT -  Dislodger, Stone, Flexible, Ureteral, Reprocessed II
  NQU -  Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed II
876.5010 Biliary catheter and accessories.    
  GCA -  Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection II
  LQR -  Dislodger, Stone, Biliary II
  NML -  Catheter, Biliary, Reprocessed II
876.5090 Suprapubic urological catheter and accessories.    
  FEW -  Catheter, Malecot II
  FFA -  Tube, Drainage, Suprapubic II
876.5130 Urological catheter and accessories.    
  EYB -  Catheter, Ureteral, Gastro-Urology II
  EYC -  Catheter, Upper Urinary Tract II
  EZC -  Catheter, Coude II
  EZD -  Catheter, Straight II
  EZL -  Catheter, Retention Type, Balloon II
  FCM -  Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) II
  FGF -  Catheter, Ureteral Disposable (X-Ray) II
  FGH -  Catheter, Double Lumen Female Urethrographic II
  FGI -  Catheter, Urethrographic, Male II
  GBL -  Catheter, Ureteral, General & Plastic Surgery N
  GBM -  Catheter, Urethral II
  KNY -  Accessories, Catheter, G-U II
  KOD -  Catheter, Urological II
  LJH -  System, Irrigation, Urological II
  MJC -  Catheter, Urological (Antimicrobial) And Accessories II
  NWO -  Kit, Catheter, Urinary (Exludes Hiv Testing) II
876.5320 Nonimplanted electrical continence device.    
  KPI -  Stimulator, Electrical, Non-Implantable, For Incontinence II
876.5470 Ureteral dilator.    
  EZN -  Dilator, Catheter, Ureteral II
876.5520 Urethral dilator.    
  FAH -  Dilator, Urethral, Mechanical II
876.5540 Blood access device and accessories.    
  FJO -  Plier, Tube I
  FKA -  Dilator, Vessel II
876.5665 Water purification system for hemodialysis.    
  FIP -  Subsystem, Water Purification II
876.5820 Hemodialysis system and accessories.    
  FIN -  Tank, Holding, Dialysis II
  FJA -  Manometer, Water II
  FJP -  Adaptor, Y II
  FJZ -  Declotting Tray, Kit (Including Contents) II
  FKH -  Solution-Test Standard-Conductivity, Dialysis II
  FKM -  Adaptor, Fistula II
  FLB -  Meter, Conductivity, Induction, Remote Type II
  MNV -  Strip, Dialysate Ph Indicator II
876.5880 Isolated kidney perfusion and transport system and accessories.    
  KDK -  Container, Transport, Kidney II
  KDN -  System, Perfusion, Kidney II
876.5980 Gastrointestinal tube and accessories.    
  BSS -  Tube, Nasogastric II
  EZK -  Catheter, Retention Type II
  FCB -  Bag, Hemostatic II
  FEF -  Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression II
  FEG -  Tube, Double Lumen For Intestinal Decompression And/Or Intubation II
  FFW -  String And Tubes, Gastrointestinal, To Locate Internal Bleeding II
  FHT -  Set, Gavage, Infant, Sterile II
  FRQ -  Tube, Levine II
  GBT -  Catheter, Rectal II
  KDH -  Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration II
  KGC -  Tube, Gastro-Enterostomy II
  LCG -  Intestinal Splinting Tubes II
  PBP -  Rectal Insert II
  EYN -  Tray, Irrigation, Sterile II
  NGU -  Balloon, Liver Tamponade II

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