FDA 510(k) K183309, stentfix OTSC System Set, by Ovesco Endoscopy AG
FDA 510(k) K183309, stentfix OTSC System Set, by Ovesco Endoscopy AG
Device Classification Name: Hemostatic Metal Clip For The Gi Tract
510(k) Number: K183309
Device Name: stentfix OTSC System Set
Applicant: Ovesco Endoscopy AG
Regulation Number: 876.44
Classification Product Code: PKL
Date Received: 2018-11-29
Decision Date: 2019-10-22
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: Gastroenterology/Urology
Total number of pages: 1,822
Fully redacted pages: 1,175
Content pages: 647
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