BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    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

    K Number: K172665 · Decision May 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    7
    Review Days
    261

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    Basic Information

    Device Name
    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
    K Number
    K172665
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wilson-Cook Medical Inc./Cook Endoscopy
    Date Received
    September 5, 2017
    Decision Date
    May 24, 2018
    Product Code
    KNS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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

    K Number Device Name
    K190829 Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
    K172288 Fusion OMNI Sphincterotome
    K171993 Zimmon Needle Knife Papillotome
    K171607 Bronchi and Gastrointestinal Cytology Brush
    K121505 DISPOSABLE HEMOSTASIS CHIP
    K111895 ECHOTIP(R) ULTRA FIDUCIAL NEEDLE