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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Recognition 07/09/2014 
FR Recognition Number 9-94
Standard
ISO 8600-4 Second Edition 2014-03-15
Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
Scope/Abstract
This International Standard specifies a method of measurement of the maximum insertion portion width of medical endoscopes and certain endoscopic accessories.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§884.1720 Laparoscope, Gynecologic (And Accessories) Class 2 HET
§884.1690 Hysteroscope (And Accessories) Class 2 HIH
§884.1640 Culdoscope (And Accessories) Class 2 HEW
§884.1630 Colposcope (And Colpomicroscope) Class 2 HEX
§884.1630 Vaginoscope And Accessories Class 2 MOK
§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
§884.1690 Falloposcope Class 2 MKO
Relevant FDA Guidance and/or Supportive Publications
Hysteroscopes and Gynecologic Laparoscopes: Submission Guidance for a 510(k), Issued March 1996.
FDA Technical Contact
 Veronica Price
  FDA/OMPT/CDRH/ODE/DRGUD/OGDB/
  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
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