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

    GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)

    K Number: K964061 · Decision Feb 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    40
    Applicant Total
    163
    Review Days
    133

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    Basic Information

    Device Name
    GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
    K Number
    K964061
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    October 10, 1996
    Decision Date
    February 20, 1997
    Product Code
    LYK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LYK Angioscope

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