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Recognized Consensus Standards
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Recognition List Number: 020 Publication Date: 09/09/2008 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 9-46: IEC 60601-2-2 2006, Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment. (ObGyn/Gastroenterology)

Date of Standard: 2006. 
Address of Standards Organization:
  International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions Associated with Recognized Standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED)
Devices Affected:
Endoscopes Electrosurgical Unit and Accessories (GI/GU), Electrohydraulic Lithotripor
Processes Affected:
510(k), PMA, IDE,PDP, HDE, Design Control Input
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§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 Gastroscope And Accessories, Flexible/Rigid Class 2 FDS
§876.1500 Mini Endoscope, Gastroenterology-Urology Class 2 ODF
§876.1500 Pancreatoscope, Biliary Class 2 FTK
§876.1500 Resectoscope Class 2 FJL
§876.1500 Sigmoidoscope And Accessories, Flexible/Rigid Class 2 FAM
§876.1500 Ureteroscope And Accessories, Flexible/Rigid Class 2 FGB
§876.1500 Urethroscope Class 2 FGC
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§876.4300 Electrode, Electrosurgical, Active, Urological Class 2 FAS
§876.4300 Electrode, Flexible Suction Coagulator Class 2 FEH
§876.4300 Forceps, Biopsy, Electric Class 2 KGE
§876.4300 Unit, Electrosurgical Class 2 FAR
§876.4300 Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Class 2 KNS
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§876.4480 Lithotriptor, Electro-Hydraulic Class 2 FFK
 
Relevant Guidance:
Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters. Issued November 30, 1998
FDA Technical Contact:
  Isaac A. Chang
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 1108
  Silver Spring MD 20993
  301/796-2789
  Email: isaac.chang@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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