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510(k) K212323

Instinct Plus Endoscopic Clipping Device by Wilson-Cook Medical, Inc. — Product Code PKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2021
Date Received
July 26, 2021
Clearance Type
Special
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 Wilson-Cook Medical, Inc.

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  • K243568 — Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (January 17, 2025)
  • K213356 — Entuit PEG, Entuit PEGJ (January 20, 2022)
  • K201322 — Entuit Nasal Jejunal Feeding Tube (June 17, 2020)
  • K200972 — Hemospray Endoscopic Hemostat (June 10, 2020)
  • K200247 — Fusion Quattro Extraction Balloon (February 27, 2020)
  • K192339 — TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord (January 30, 2020)
  • K193344 — Tri-Ex Extraction Balloon with Multiple Sizing (December 13, 2019)
  • K192908 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes (November 14, 2019)
  • K191048 — AcuSnare Polypectomy Snare - Duckbill (July 18, 2019)

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)