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

    Fusion OMNI Sphincterotome

    K Number: K172288 · Decision Apr 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    7
    Review Days
    260

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    Basic Information

    Device Name
    Fusion OMNI Sphincterotome
    K Number
    K172288
    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
    July 31, 2017
    Decision Date
    April 17, 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)
    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
    K171993 Zimmon Needle Knife Papillotome
    K171607 Bronchi and Gastrointestinal Cytology Brush
    K121505 DISPOSABLE HEMOSTASIS CHIP
    K111895 ECHOTIP(R) ULTRA FIDUCIAL NEEDLE