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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 K171692
Device Name Instrument basket, for EndoEYE
Applicant
Olympus Winter & Ibe GmbH
Kuehnstr, 61
Hamburg,  DE 22045
Applicant Contact Jan-Oliver Upmeier
Correspondent
Olympus Corporation of the Americas
3500 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact Sheri L. Musgnung
Regulation Number880.6850
Classification Product Code
KCT  
Date Received06/07/2017
Decision Date 04/02/2018
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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