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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 K253481
Device Name colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)
Applicant
Ovesco Endoscopy AG
Friedrich-Miescher-Strasse 9
Tuebingen,  DE 72076
Applicant Contact Antonio Caputo
Correspondent
Novineon CRO GmbH
Friedrich-Miescher-Strasse 9
Tuebingen,  DE 72076
Correspondent Contact Maria Kiel
Regulation Number876.4400
Classification Product Code
PKL  
Subsequent Product Codes
FDI   KNS   OCZ  
Date Received10/14/2025
Decision Date 09/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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