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510(k) K172288

Fusion OMNI Sphincterotome by Wilson-Cook Medical Inc./Cook Endoscopy — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2018
Date Received
July 31, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Wilson-Cook Medical Inc./Cook Endoscopy

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  • K172665 — Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton (May 24, 2018)
  • K171993 — Zimmon Needle Knife Papillotome (August 17, 2017)
  • K171607 — Bronchi and Gastrointestinal Cytology Brush (July 31, 2017)
  • K121505 — DISPOSABLE HEMOSTASIS CHIP (August 31, 2012)
  • K111895 — ECHOTIP(R) ULTRA FIDUCIAL NEEDLE (April 27, 2012)

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  • K242774 — SpydrBlade Flex Instrument (PRD-RG1-001) (June 6, 2025)
  • K241855 — SB Knife Jr2 (MD-47702 and MD-47702L) (March 26, 2025)
  • K242192 — Disposable Sphincterotome (February 6, 2025)