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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Metal Clip For The Gi Tract
510(k) Number K251562
Device Name OTSCneo System Set (100.03n-14n, 100.27n-31n)
Applicant
Ovesco Endoscopy AG
Friedrich-Miescher-Strasse 9
Tuebingen,  DE 72076
Applicant Contact Christoph Mielke
Correspondent
Novineon CRO GmbH
Friedrich-Miescher-Strasse 9
Tuebingen,  DE 72076
Correspondent Contact Natalja Klymov
Regulation Number876.4400
Classification Product Code
PKL  
Date Received05/22/2025
Decision Date 12/18/2025
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		 Yes
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