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

    STRYKER VENOM ELECTRODES AND CANNULAE

    K Number: K123178 · Decision Mar 28, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    65
    Applicant Total
    6
    Review Days
    170

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    Basic Information

    Device Name
    STRYKER VENOM ELECTRODES AND CANNULAE
    K Number
    K123178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4725
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Instruments, Instruments Div.
    Date Received
    October 9, 2012
    Decision Date
    March 28, 2013
    Product Code
    GXI
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXI Probe, Radiofrequency Lesion

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