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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 K200369
Device Name OES Elite Ureteroscopes and Accessories
Applicant
Olympus Winter & Ibe GmbH
Kuehnstr, 61
Hamburg,  DE 22045
Applicant Contact Stefanie Weber
Correspondent
Olympus Surgical Technologies America
118 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact Christina Flores
Regulation Number876.1500
Classification Product Code
FGB  
Date Received02/14/2020
Decision Date 08/28/2020
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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