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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.


Gastroenterology

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

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