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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Recognition List Number: 028 Publication Date: 03/16/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 9-53: ASTM F 1992 -99 (Reapproved 2007), Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes. (ObGyn/Gastroenterology)

Date of Standard: 1999. 
Address of Standards Organization:
  ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Flexible Fiberoptic and Video Endoscopes Used in the Examination of Hollow Viscera
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard.

Practice standard for users.
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§876.1075 Biopsy Needle Kit Class 2 FCG
§876.1075 Forceps, Biopsy, Non-Electric Class 1 FCL
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§876.1500 Accessories, Cleaning Brushes, For Endoscope Class 1 MNL
§876.1500 Apparatus, Pneumoperitoneum, Automatic Class 2 FDP
§876.1500 Carrier, Sponge, Endoscopic Class 2 FGS
§876.1500 Device, Measuring, For Panendoscope Class 1 FDY
§876.1500 Endoscope Holder Class 2 OCV
§876.1500 Endoscopic Grasping/Cutting Instrument, Non-Powered Class 2 OCZ
§876.1500 Endoscopic Guidewire, Gastroenterology-Urology Class 2 OCY
§876.1500 Endoscopic Injection Needle, Gastroenterology-Urology Class 2 FBK
§876.1500 Endoscopic Irrigation/Suction System Class 2 OCX
§876.1500 Mini Endoscope, Gastroenterology-Urology Class 2 ODF
§876.1500 Needle, Pneumoperitoneum, Simple Class 2 FHP
§876.1500 Obturator, For Endoscope Class 2 FEC
§876.1500 Pneumoperitoneum Needle Class 2 FHO
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§876.4300 Electrode, Flexible Suction Coagulator Class 2 FEH
§876.4300 Forceps, Biopsy, Electric Class 2 KGE
§876.4300 Snare, Flexible Class 2 FDI
§876.4300 Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Class 2 KNS
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§876.4680 Dislodger, Stone, Basket, Ureteral, Metal Class 2 FFL
§876.4680 Dislodger, Stone, Flexible Class 2 FGO
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§876.4730 Snare, Non-Electrical Class 1 FGX
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§876.5365 Dilator, Esophageal Class 2 KNQ
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§878.4400 Electrosurgical, Cutting & Coagulation & Accessories Class 2 GEI
 
Relevant Guidance:
Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA, Issued August 30, 2002
FDA Technical Contact:
  Janine Morris
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room G208
  Silver Spring MD 20993
  301/796-5706
  Email: janine.morris@fda.hhs.gov
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