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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K203492
Device Name Instrument tray, for semi-rigid ureteroscope
Applicant
Olympus Winter & Ibe GmbH
Kuehnstr, 61
Hamburg,  DE 22045
Applicant Contact Jan-Oliver Upmeier
Correspondent
Olympus Surgical Technologies America
118 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact Dolan Mills
Regulation Number880.6850
Classification Product Code
KCT  
Date Received11/19/2020
Decision Date 09/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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