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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K011849
Device Name MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS
Applicant
Circon Video
6500 Hollister Ave.
Santa Barbara,  CA  93117 -3019
Applicant Contact WAYNE B STERNER
Correspondent
Circon Video
6500 Hollister Ave.
Santa Barbara,  CA  93117 -3019
Correspondent Contact WAYNE B STERNER
Regulation Number876.1500
Classification Product Code
FGB  
Date Received06/13/2001
Decision Date 12/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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