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510(k) K171993

Zimmon Needle Knife Papillotome by Wilson-Cook Medical Inc./Cook Endoscopy — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2017
Date Received
July 3, 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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  • K172288 — Fusion OMNI Sphincterotome (April 17, 2018)
  • 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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