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

    STRYKER RF ELECTRODES AND CANNULAE

    K Number: K032406 · Decision Apr 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    65
    Applicant Total
    74
    Review Days
    241

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    Basic Information

    Device Name
    STRYKER RF ELECTRODES AND CANNULAE
    K Number
    K032406
    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
    Date Received
    August 4, 2003
    Decision Date
    April 1, 2004
    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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