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

    AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX

    K Number: K010008 · Decision Jul 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    138
    Applicant Total
    1
    Review Days
    195

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    Basic Information

    Device Name
    AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX
    K Number
    K010008
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5880
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micronet Medical, Inc.
    Date Received
    January 2, 2001
    Decision Date
    July 16, 2001
    Product Code
    GZB
    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
    GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)

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