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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 9-130
Standard
ISO 8600-6 Second edition 2020-09
Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
Scope/Abstract
This document defines terms for endoscopes and endotherapy devices commonly used in the endoscopic area. This document does not define general medical terms or other general terms. This document does not define terms that should be defined in other ISO 8600 (all parts).
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FDA recognition of ISO 8600-6 First edition 2005-03-15 [Rec# 9-40] will be superseded by recognition of ISO 8600-6 Second edition 2020-09 [Rec# 9-130]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-40] until December 19, 2021. After this transition period, declarations of conformity to [Rec# 9-40] 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
§876.1500 Angioscope Class 2 LYK
§876.1500 Anoscope And Accessories Class 2 FER
§876.1500 Choledochoscope And Accessories, Flexible/Rigid Class 2 FBN
§876.1500 Colonoscope And Accessories, Flexible/Rigid Class 2 FDF
§876.1500 Cystoscope And Accessories, Flexible/Rigid Class 2 FAJ
§876.1500 Cystourethroscope Class 2 FBO
§876.1500 Duodenoscope And Accessories, Flexible/Rigid Class 2 FDT
§876.1500 Endoscope, Flexible Class 2 GCQ
§876.1500 Endoscope, Rigid Class 2 GCM
§876.1500 Enteroscope And Accessories Class 2 FDA
§876.1500 Kit, Nephroscope Class 2 FGA
§876.1500 Laparoscope, General & Plastic Surgery Class 2 GCJ
§876.1500 Resectoscope Class 2 FJL
§876.1500 Sigmoidoscope And Accessories, Flexible/Rigid Class 2 FAM
§876.1500 Sigmoidoscope, Rigid, Electrical Class 2 FAN
§876.1500 Telescope, Rigid, Endoscopic Class 2 FBP
§876.1500 Ureteroscope And Accessories, Flexible/Rigid Class 2 FGB
§876.1500 Urethroscope Class 2 FGC
§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 Falloposcope Class 2 MKO
§884.1690 Hysteroscope (And Accessories) Class 2 HIH
§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.
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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