• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 060 Date of Entry 05/29/2023 
FR Recognition Number 9-146
Standard
ISO  8600-4 Third Edition 2023-01
Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
Scope/Abstract
This document specifies a method of measurement of the maximum insertion portion width of medical endoscopes and certain endoscopic accessories.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO 8600-4 Second Edition 2014-03-15 [Rec# 9-94] will be superseded by recognition of ISO 8600-4 Third Edition 2023-01 [Rec# 9-146]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-94] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 9-94] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§874.4680 Bronchoscope (Flexible Or Rigid) Class 2 EOQ
§874.4710 Esophagoscope (Flexible Or Rigid) Class 2 EOX
§874.4760 Nasopharyngoscope (Flexible Or Rigid) Class 2 EOB
§876.1300 System, Imaging, Gastrointestinal, Wireless, Capsule Class 2 NEZ
§876.1300 System, Imaging, Esophageal, Wireless, Capsule Class 2 NSI
§876.1310 Magnetically Maneuvered Capsule Endoscopy System Class 2 QKZ
§876.1330 Colon Capsule Imaging System Class 2 PGD
§876.1500 Cystoscope And Accessories, Flexible/Rigid Class 2 FAJ
§876.1500 Panendoscope (Gastroduodenoscope) Class 2 FAK
§876.1500 Panendoscope (Urethroscope) Class 2 FAL
§876.1500 Sigmoidoscope And Accessories, Flexible/Rigid Class 2 FAM
§876.1500 Sigmoidoscope, Rigid, Electrical Class 2 FAN
§876.1500 Choledochoscope And Accessories, Flexible/Rigid Class 2 FBN
§876.1500 Cystourethroscope Class 2 FBO
§876.1500 Telescope, Rigid, Endoscopic Class 2 FBP
§876.1500 Enteroscope And Accessories Class 2 FDA
§876.1500 Laparoscopy Kit Class 2 FDE
§876.1500 Colonoscope And Accessories, Flexible/Rigid Class 2 FDF
§876.1500 Sphyncteroscope Class 2 FDR
§876.1500 Gastroscope And Accessories, Flexible/Rigid Class 2 FDS
§876.1500 Duodenoscope And Accessories, Flexible/Rigid Class 2 FDT
§876.1500 Esophagoscope, Rigid, Gastro-Urology Class 2 FDW
§876.1500 Anoscope And Accessories Class 2 FER
§876.1500 Kit, Nephroscope Class 2 FGA
§876.1500 Ureteroscope And Accessories, Flexible/Rigid Class 2 FGB
§876.1500 Urethroscope Class 2 FGC
§876.1500 Resectoscope Class 2 FJL
§876.1500 Colonoscope, General & Plastic Surgery Class 2 FTJ
§876.1500 Proctoscope Class 2 GCF
§876.1500 Peritoneoscope Class 2 GCG
§876.1500 Mediastinoscope, Diagnostic Class 2 GCH
§876.1500 Laryngoscope, Endoscope Class 2 GCI
§876.1500 Laparoscope, General & Plastic Surgery Class 2 GCJ
§876.1500 Gastroscope, General & Plastic Surgery Class 2 GCK
§876.1500 Esophagoscope, General & Plastic Surgery Class 2 GCL
§876.1500 Endoscope, Ac-Powered And Accessories Class 2 GCP
§876.1500 Endoscope, Flexible Class 2 GCQ
§876.1500 Endoscope, Battery-Powered And Accessories Class 2 GCS
§876.1500 Endoscope, Fiber Optic Class 2 GDB
§876.1500 Sigmoidoscope, Rigid, Non-Electrical Class 2 KDM
§876.1500 Endoscope, Ophthalmic Class 2 KYH
§876.1500 Angioscope Class 2 LYK
§876.1500 Endoscope, Accessories, Narrow Band Spectrum Class 2 NWB
§876.1500 Kit, Choledochoscope, Flexible And Rigid Class 2 NWS
§876.1500 Endoscopic Cholangiogram Kit Class 2 NWT
§876.1500 Mini Endoscope, Gastroenterology-Urology Class 2 ODF
§884.1630 Colposcope (And Colpomicroscope) Class 2 HEX
§884.1630 Vaginoscope And Accessories Class 2 MOK
§884.1640 Culdoscope (And Accessories) Class 2 HEW
§884.1690 Hysteroscope (And Accessories) Class 2 HIH
§884.1690 Falloposcope Class 2 MKO
§884.1720 Laparoscope, Gynecologic (And Accessories) Class 2 HET
§884.1720 Laparoscope And Accessories, Gynecologic, Reprocessed Class 2 NMH
§884.1720 Gynecological Laparoscopic Kit Class 2 OHD
Relevant FDA Guidance and/or Supportive Publications*
Hysteroscopes and Gynecologic Laparoscopes: Submission Guidance for a 510(k), issued March 1996.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Veronica Price
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/
  301-796-6538
  veronica.price@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
-
-