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

    DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE

    K Number: K100912 · Decision Aug 19, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    52
    Applicant Total
    18
    Review Days
    140

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    Basic Information

    Device Name
    DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
    K Number
    K100912
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1350
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kirwan Surgical Products, Inc.
    Date Received
    April 1, 2010
    Decision Date
    August 19, 2010
    Product Code
    GXZ
    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
    GXZ Electrode, Needle

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