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Recognized Consensus Standards
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 030 Date of Entry 01/15/2013 
FR Recognition Number 9-39
Standard
ISO 8600-5 First edition 2005-03-15
Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
Scope/Abstract
This part of ISO 8600 specifies a test method for determining the optical resolution of endoscopes for type testing. It is applicable to rigid endoscopes with optics designed for use in the practice of medicine for type testing. It is not applicable to endoscopes having a fibre-optic or opto-electronic imaging system.
Extent of Recognition
Complete standard
Transition Period
FDA recognition of ISO 8600-5 First edition 2005-03-15 [Rec# 9-39] will be superseded by recognition of ISO 8600-5 Second Edition 2020-10 [Rec# 9-131]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-39] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 9-39] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§884.1690 Falloposcope Class 2 MKO
Regulation Number Device Name Device Class Product Code
§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
Regulation Number Device Name Device Class Product Code
§884.1630 Colposcope (And Colpomicroscope) Class 2 HEX
§884.1630 Vaginoscope And Accessories Class 2 MOK
Regulation Number Device Name Device Class Product Code
§884.1640 Culdoscope (And Accessories) Class 2 HEW
Regulation Number Device Name Device Class Product Code
§884.1690 Hysteroscope (And Accessories) Class 2 HIH
Regulation Number Device Name Device Class Product Code
§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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