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

    STRYKER INTERVENTIONAL PAIN RF GENERATOR

    K Number: K032601 · Decision Apr 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    36
    Applicant Total
    27
    Review Days
    220

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    Basic Information

    Device Name
    STRYKER INTERVENTIONAL PAIN RF GENERATOR
    K Number
    K032601
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Valley Forge Scientific Corp.
    Date Received
    August 25, 2003
    Decision Date
    April 1, 2004
    Product Code
    GXD
    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
    GXD Generator, Lesion, Radiofrequency

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