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

    NEUROPACE BURR HOLE COVER MODEL 8110

    K Number: K123163 · Decision Jan 18, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    28
    Applicant Total
    2
    Review Days
    101

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    Basic Information

    Device Name
    NEUROPACE BURR HOLE COVER MODEL 8110
    K Number
    K123163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5250
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    NeuroPace, Inc.
    Date Received
    October 9, 2012
    Decision Date
    January 18, 2013
    Product Code
    GXR
    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
    GXR Cover, Burr Hole

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    Other Clearances by NeuroPace, Inc.

    K Number Device Name
    K141368 NEUROPACE BURR HOLE COVER