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510(k) K200684

gastroduodenal FTRD Set by Ovesco Endoscopy AG — Product Code PKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2020
Date Received
March 16, 2020
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)
  • 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)
  • K141790 — AQANIFE (March 6, 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)