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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Entry 04/04/2016 
FR Recognition Number 9-110
Standard
ISO  8600-1 Fourth Edition 2015-10-15
Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
Scope/Abstract
ISO 8600-1:2015 gives definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§876.1500 Cystoscope And Accessories, Flexible/Rigid Class 2 FAJ
§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 Colonoscope And Accessories, Flexible/Rigid Class 2 FDF
§876.1500 Duodenoscope And Accessories, Flexible/Rigid Class 2 FDT
§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 Laparoscope, General & Plastic Surgery Class 2 GCJ
§876.1500 Endoscope, Rigid Class 2 GCM
§876.1500 Endoscope, Flexible Class 2 GCQ
§876.1500 Angioscope Class 2 LYK
§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
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
 Quanzeng Wang
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2612
  quanzeng.wang@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.
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