510(k) K101428

OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET by Ovesco Endoscopy AG — Product Code PKL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 1, 2010
Date Received: May 21, 2010
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Hemostatic Metal Clip For The Gi Tract
Device Class: Class II
Regulation Number: 876.4400
Review Panel: GU
Submission Type

Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.

Other clearances by Ovesco Endoscopy AG

K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n) (December 18, 2025)
K242586 — ArgoCap (200.52) (May 22, 2025)
K241858 — BARS Set (100.60) (August 26, 2024)
K221385 — LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) (August 11, 2022)
K200684 — gastroduodenal FTRD Set (June 2, 2020)
K183309 — stentfix OTSC System Set (October 22, 2019)
DEN160014 — remOVE System (December 22, 2017)
K170867 — FTRD System Set (July 25, 2017)
K153550 — FTRD System Set (October 12, 2016)
K150067 — OTSC Proctology (September 16, 2015)

Other clearances for product code PKL

K253734 — Taurus Clip (March 12, 2026)
K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n) (December 18, 2025)
K252271 — Hemoclip (November 12, 2025)
K250229 — Dual Action Tissue Closure Device (September 8, 2025)
K250842 — PADLOCK CLIP EFTR Kit (00713229) (April 18, 2025)
K250066 — Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M0052 (February 6, 2025)
K241005 — Haemostasis Clips (January 2, 2025)
K240274 — PADLOCK CLIP EFTR Kit (00713229) (September 17, 2024)
K241858 — BARS Set (100.60) (August 26, 2024)
K234124 — Single Use Hemoclips (July 12, 2024)