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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 K181451
Device Name URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-Cho
Hachioji-Shi,  JP 192-8507
Applicant Contact Toshiyuki Nakajima
Correspondent
Olympus Surgical Technologies America
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Correspondent Contact Sheri L. Musgnung
Regulation Number876.1500
Classification Product Code
FGB  
Subsequent Product Codes
FBN   NWB  
Date Received06/01/2018
Decision Date 01/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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