Home / 510(k) Clearances / K172665

510(k) K172665

Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords by Wilson-Cook Medical Inc./Cook Endoscopy — Product Code KNS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 24, 2018
Date Received: September 5, 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

K190829 — Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) (December 19, 2019)
K172288 — Fusion OMNI Sphincterotome (April 17, 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)

Other clearances for product code KNS

K252388 — Vanquish Water Vapor Ablation Device (November 26, 2025)
K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (November 25, 2025)
K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Si (October 17, 2025)
K250351 — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical (October 10, 2025)
K251104 — SureTome SW Sphincterotome with DomeTip (September 29, 2025)
K251226 — Aqua Medical RF Vapor Ablation System (August 8, 2025)
K250584 — Rezum System (June 11, 2025)
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)