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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: February 7, 2002

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This page lists devices currently eligible for third-party review under the FDA's Accredited Persons Program. Premarket notifications ["510(k)'s"] for devices on this list can be submitted to FDA-accredited third parties (Accredited Persons) in lieu of FDA. Information on the Accredited Persons Program, including links to this page and to a list of Accredited Persons, is available at the Accredited Persons Inspection Program website.

The following topics are discussed in this introduction to the list of eligible devices:

  • How to use the list of eligible devices
  • Some important exceptions to the list
  • Expansion pilot

How to Use the List of Eligible Devices

The list has five 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 indicates if a device (product code) is included in the expansion pilot, described below, by showing the word "pilot." If this column is blank, the device is eligible for review under the pre-existing program and is not part of the expansion pilot.
  • The fifth column provides a link to device-specific guidance, if available, or to general guidance to assist manufacturers in the preparation-and Accredited Persons in the review-of 510(k)'s for eligible devices. Links are not provided for devices in the expansion pilot; device-specific guidance does not exist for these devices, and special procedures apply to the review of 510(k)'s for these devices by Accredited Persons, as discussed in FDA's January 2001 procedural guidance for the Accredited Persons Program, cited below.
Some Important Exceptions to the List

There are some exceptions that are not reflected in the eligible device list:

  • A device may be eligible even if it does not appear on the list if it is a Class I or Class II device that has been exempted from 510(k) by regulation, but requires a 510(k) because it exceeds the limitations of the exemption (as discussed in FDA's device classification regulations). Devices that are exempt from 510(k) are not shown on the list.
  • A Class II device on the list is ineligible if a 510(k) for the device requires clinical data to demonstrate substantial equivalence. This exception is discussed in FDA's procedural guidance for the Accredited Persons Program, cited below.
  • A device on the list is ineligible if a 510(k) for the device requires multi-Center review (e.g., 510(k)'s for drug/device combination products) or if a Center other than CDRH (e.g., the Center for Biologics Evaluation and Research) has primary responsibility for review.
Expansion Pilot

In an effort to encourage greater use of the Accredited Persons Program, FDA expanded the third party pilot to permit Accredited Persons to review many Class II devices that were not previously eligible. The expanded pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. Information on the expansion pilot, including criteria allowing for the review of these Class II devices, can be found in the guidance document entitled Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties. Accredited Persons and other interested parties should refer to Section II.B., Purpose and Nature of the Program, for the criteria that would allow for the review of the Class II devices in the expansion pilot.


Gastroenterology

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Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
876.1075 GASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT II  
  FCF -  Instrument, Biopsy, Mechanical, Gastrointestinal      
  FCG -  Biopsy Needle Kit      
  FCI -  Punch, Biopsy      
  FCK -  Instrument, Biopsy, Suction      
  KNW -  Instrument, Biopsy      
876.1500 ENDOSCOPE AND ACCESSORIES II  
Guidance Withdrawn
  LYK -  Angioscope   Pilot  
  FAJ -  Cystoscope And Accessories, Flexible/Rigid      
  FAK -  Panendoscope (Gastroduodenoscope)      
  FAL -  Panendoscope (Urethroscope)      
  FAM -  Sigmoidoscope And Accessories, Flexible/Rigid      
  FAN -  Sigmoidoscope, Rigid, Electrical      
  FBI -  Rongeur, Cystoscopic      
  FBK -  Endoscopic Injection Needle, Gastroenterology-Urology      
  FBN -  Choledochoscope And Accessories, Flexible/Rigid      
  FBO -  Cystourethroscope      
  FBP -  Telescope, Rigid, Endoscopic      
  FCC -  Endscopic Magnetic Retriever      
  FCQ -  Light Source, Incandescent, Diagnostic      
  FCR -  Light Source, Photographic, Fiberoptic      
  FCW -  Light Source, Fiberoptic, Routine      
  FCX -  Insufflator, Automatic Carbon-Dioxide For Endoscope      
  FDA -  Enteroscope And Accessories      
  FDC -  Resectoscope, Working Element      
  FDE -  Laparoscopy Kit      
  FDF -  Colonoscope And Accessories, Flexible/Rigid      
  FDP -  Apparatus, Pneumoperitoneum, Automatic      
  FDR -  Sphyncteroscope      
  FDS -  Gastroscope And Accessories, Flexible/Rigid      
  FDT -  Duodenoscope And Accessories, Flexible/Rigid      
  FDW -  Esophagoscope, Rigid, Gastro-Urology      
  FDX -  Endoscopic Cytology Brush      
  FEB -  Accessories, Cleaning, For Endoscope      
  FEC -  Obturator, For Endoscope      
  FED -  Endoscopic Access Overtube, Gastroenterology-Urology      
  FEQ -  Pump, Air, Non-Manual, For Endoscope      
  FER -  Anoscope And Accessories      
  FET -  Endoscopic Video Imaging System/Component, Gastroenterology-Urology      
  FFS -  Image, Illumination, Fiberoptic, For Endoscope      
  FFZ -  Cord, Electric, For Endoscope      
  FGA -  Kit, Nephroscope      
  FGB -  Ureteroscope And Accessories, Flexible/Rigid      
  FGC -  Urethroscope      
  FGS -  Carrier, Sponge, Endoscopic      
  FHO -  Pneumoperitoneum Needle      
  FHP -  Needle, Pneumoperitoneum, Simple      
  FHX -  Jelly, Lubricating, For Transurethral Surgical Instrument      
  FJL -  Resectoscope      
  FTI -  Lamp, Endoscope, Incandescent      
  FTJ -  Colonoscope, General & Plastic Surgery      
  FTK -  Pancreatoscope, Biliary      
  GCF -  Proctoscope      
  GCG -  Peritoneoscope      
  GCH -  Mediastinoscope, Diagnostic      
  GCI -  Laryngoscope, Endoscope      
  GCK -  Gastroscope, General & Plastic Surgery      
  GCL -  Esophagoscope, General & Plastic Surgery      
  GCM -  Endoscope, Rigid      
  GCN -  Endoscope, Prism      
  GCO -  Endoscope, Mirror      
  GCP -  Endoscope, Ac-Powered And Accessories      
  GCQ -  Endoscope, Flexible      
  GCS -  Endoscope, Battery-Powered And Accessories      
  GCT -  Light Source, Endoscope, Xenon Arc      
  GCW -  Transformer, Endoscope      
  GDB -  Endoscope, Fiber Optic      
  KDM -  Sigmoidoscope, Rigid, Non-Electrical      
  KDO -  Rongeur, Cystoscopic, Hot      
  KGD -  Scissors For Cystoscope      
  KOG -  Endoscope And/Or Accessories      
  NTN -  Led Light Source      
  OCV -  Endoscope Holder   Pilot  
  OCY -  Endoscopic Guidewire, Gastroenterology-Urology      
  KYH -  Endoscope, Ophthalmic   Pilot  
  MPA -  Endoilluminator   Pilot  
  GCJ -  Laparoscope, General & Plastic Surgery      
876.1725 GASTROINTESTINAL MOTILITY MONITORING SYSTEM II  
  FES -  Recorder, External, Pressure, Amplifier & Transducer   Pilot  
  FFX -  System, Gastrointestinal Motility (Electrical)   Pilot  
  KLA -  Monitor, Esophageal Motility, And Tube   Pilot  
876.4020 FIBEROPTIC LIGHT URETERAL CATHETER II  
  FCS -  Light, Catheter, Fiberoptic, Glass, Ureteral   Pilot  
876.4270 COLOSTOMY ROD II  
  EZP -  Rod, Colostomy   Pilot  
876.4300 ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES II  
Guidance Withdrawn
  FAR -  Unit, Electrosurgical      
  FAS -  Electrode, Electrosurgical, Active, Urological      
  FBJ -  Cord, Electric For Transurethral Surgical Instrument      
  FDB -  Plate, Patient      
  FDI -  Snare, Flexible      
  FDJ -  Snare, Rigid Self-Opening      
  FDL -  Wristlet, Patient Return      
  FEH -  Electrode, Flexible Suction Coagulator      
  FFI -  System, Alarm, Electrosurgical      
  FGW -  Clamp, Electrical      
  FHC -  Adaptor To The Cord, For Transurethral Surgical Instrument      
  FHY -  Jelly, Contact, For Transurethral Surgical Instrument      
  FHZ -  Desiccator, Transurethral      
  KGE -  Forceps, Biopsy, Electric      
  KNS -  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)      
876.4400 HEMORRHOIDAL LIGATOR II  
  FHN -  Ligator, Hemorrhoidal   Pilot  
  MND -  Ligator, Esophageal   Pilot  
876.4480 ELECTROHYDRAULIC LITHOTRIPTOR II  
  FFK -  Lithotriptor, Electro-Hydraulic      
876.4500 MECHANICAL LITHOTRIPTOR II  
  HTML Guidance file for MECHANICAL LITHOTRIPTOR (21CFR876.4500)
  FGK -  Tripsor, Stone, Bladder      
  LQC -  Lithotriptor, Biliary Mechanical      
876.4620 URETERAL STENT II  
  FAD -  Stent, Ureteral      
876.4730 MANUAL GASTROENTEROLOGY-UROLOGY SURGICAL INSTRUMENT AND ACCESSORIES I  
 General Guidance
  OOW -  Applicator For Rectal Suppository      
876.4770 URETHROTOME II  
  EZO -  Urethrotome   Pilot  
876.5010 BILIARY CATHETER AND ACCESSORIES II  
  HTML Guidance file for BILIARY CATHETER AND ACCESSORIES (21CFR876.5010)
  EXF -  Bag, Bile Collecting   Pilot  
  GCA -  Catheter, Biliary, Surgical   Pilot  
  LQR -  Dislodger, Stone, Biliary      
876.5090 SUPRAPUBIC UROLOGICAL CATHETER AND ACCESSORIES II  
  FEW -  Catheter, Malecot   Pilot  
  FFA -  Tube, Drainage, Suprapubic   Pilot  
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      
  MJC -  Catheter, Urological (Antimicrobial) And Accessories      
876.5160 UROLOGICAL CLAMPS FOR MALES I  
PDF Guidance file for UROLOGICAL CLAMPS FOR MALES (21CFR876.5160)  
  FHA -  Clamp, Penile      
876.5320 NONIMPLANTED ELECTRICAL CONTINENCE DEVICE II  
Guidance Withdrawn
  KPI -  Stimulator, Electrical, Non-Implantable, For Incontinence      
876.5365 ESOPHAGEAL DILATOR II  
  EZM -  Dilator, Esophageal (Metal Olive) Gastro-Urology   Pilot  
  FAT -  Bougie, Esophageal, And Gastrointestinal, Gastro-Urology   Pilot  
  KNQ -  Dilator, Esophageal   Pilot  
876.5470 URETERAL DILATOR II  
  EZN -  Dilator, Catheter, Ureteral   Pilot  
876.5520 URETHRAL DILATOR II  
  FAH -  Dilator, Urethral, Mechanical   Pilot  
  KOE -  Dilator, Urethral   Pilot  
876.5540 BLOOD ACCESS DEVICE AND ACCESSORIES II  
  FKA -  Dilator, Vessel   Pilot  
876.5665 WATER PURIFICATION SYSTEM FOR DIALYSIS II  
  FIP -  Subsystem, Water Purification      
876.5820 HEMODIALYSIS SYSTEMS AND ACCESSORIES II  
  FIN -  Tank, Holding, Dialysis   Pilot  
  FJA -  Manometer, Water   Pilot  
  FJP -  Adaptor, Y   Pilot  
  FJZ -  Declotting Tray, Kit (Including Contents)   Pilot  
  FKH -  Solution-Test Standard-Conductivity, Dialysis   Pilot  
  FKI -  Set, Dialyzer Holder   Pilot  
  FKM -  Adaptor, Fistula   Pilot  
  FKS -  Chair, Dialysis, Powered, Without Scales   Pilot  
  FLB -  Meter, Conductivity, Induction, Remote Type   Pilot  
  MNV -  Strip, Dialysate Ph Indicator   Pilot  
876.5880 ISOLATED KIDNEY PERFUSION AND TRANSPORT SYSTEM AND ACCESSORIES II  
  KDK -  Container, Transport, Kidney   Pilot  
  KDN -  System, Perfusion, Kidney   Pilot  
876.5895 OSTOMY IRRIGATOR II  
  EXD -  Irrigator, Ostomy   Pilot  
876.5980 GASTROINTESTINAL TUBE AND ACCESSORIES II  
  BSS -  Tube, Nasogastric   Pilot  
  EYN -  Tray, Irrigation, Sterile   Pilot  
  EZK -  Catheter, Retention Type   Pilot  
  FCB -  Bag, Hemostatic   Pilot  
  FEF -  Tube, Single Lumen, W Mercury Wt Balloon For Intes. Intub. &/Or Decompression   Pilot  
  FEG -  Tube, Double Lumen For Intestinal Decompression And/Or Intubation   Pilot  
  FFW -  String And Tubes, Gastrointestinal, To Locate Internal Bleeding   Pilot  
  FHT -  Set, Gavage, Infant, Sterile   Pilot  
  FPD -  Tube, Feeding   Pilot  
  FRQ -  Tube, Levine   Pilot  
  GBT -  Catheter, Rectal   Pilot  
  KDH -  Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration   Pilot  
  KGC -  Tube, Gastro-Enterostomy   Pilot  
  KNT -  Tubes, Gastrointestinal (And Accessories)   Pilot  
  LCG -  Intestinal Splinting Tubes   Pilot  
  NGU -  Balloon, Liver Tamponade   Pilot  

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