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

    WILTEK POLYPECTOMY SNARE

    K Number: K894869 · Decision Dec 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    62
    Applicant Total
    21
    Review Days
    143

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    Basic Information

    Device Name
    WILTEK POLYPECTOMY SNARE
    K Number
    K894869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Wiltek Medical, Inc.
    Date Received
    July 31, 1989
    Decision Date
    December 21, 1989
    Product Code
    FDI
    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
    FDI Snare, Flexible

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