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510(k) K251562

OTSCneo System Set (100.03n-14n, 100.27n-31n) by Ovesco Endoscopy AG — Product Code PKL

K251562 is an FDA 510(k) premarket notification submitted by Ovesco Endoscopy AG for the device "OTSCneo System Set (100.03n-14n, 100.27n-31n)". The FDA issued a decision of Substantially Equivalent on December 18, 2025. The device falls under product code PKL (Hemostatic Metal Clip For The Gi Tract), a Class II device regulated under 21 CFR 876.4400. Ovesco Endoscopy AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2025
Date Received
May 22, 2025
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

  • 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)
  • K141790 — AQANIFE (March 6, 2015)

Other clearances for product code PKL

  • K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX (May 21, 2026)
  • K252270 — Hemoclip (April 8, 2026)
  • K253734 — Taurus Clip (March 12, 2026)
  • 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)

FDA data resources