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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 9-94: ISO 8600-4 Second Edition 2014-03-15, optics and optical instruments -- medical endoscopes and certain accessories -- part 4: determination of maximum width of insertion portion. (ObGyn/Gastroenterology)

Date of Standard: 2014. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Endoscopes and accessories used to review the gastrointestinal (GI) tract (esophagogastroduodenoscope, enteroscope, colonoscope, sigmoidoscope, rectoscope, etc.), the respiratory tract (rhinoscope, bronchoscope, etc.), the urinary tract (cystoscope, etc.), the female reproductive system (colposcope, hysteroscope, falloposcope, etc.), and normally closed body cavities (laparoscope, arthroscope, thoracoscope, fetoscope, culdoscope, breast ductoscope, etc.
Processes Affected:
510(k), PMA, IDE, Design Control Input, QSR
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§884.1690 Falloposcope Class 2 MKO
§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 And/Or Accessories Class 2 KOG
§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 Hysteroscope (And Accessories) Class 2 HIH
§884.1720 Laparoscope, Gynecologic (And Accessories) Class 2 HET
Relevant Guidance:
Hysteroscopes and Gynecologic Laparoscopes Submission Guidance for a 510(k). Issued March 7, 1996
FDA Technical Contact:
 Veronica Price
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room G116
  Silver Spring MD 20993
  301/796-6538
  email: veronica.price@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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