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

    MULTI-LEAD TRIALING CABLE MODEL 355531

    K Number: K102523 · Decision Oct 26, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    138
    Applicant Total
    209
    Review Days
    54

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    Basic Information

    Device Name
    MULTI-LEAD TRIALING CABLE MODEL 355531
    K Number
    K102523
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5880
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic, Inc.
    Date Received
    September 2, 2010
    Decision Date
    October 26, 2010
    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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