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

    OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS

    K Number: K112214 · Decision Nov 17, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    138
    Applicant Total
    2
    Review Days
    107

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    Basic Information

    Device Name
    OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
    K Number
    K112214
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5880
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    St. Jude Medical Neuromodulation
    Date Received
    August 2, 2011
    Decision Date
    November 17, 2011
    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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