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

    DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES

    K Number: K053363 · Decision May 30, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    31
    Applicant Total
    18
    Review Days
    179

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    Basic Information

    Device Name
    DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
    K Number
    K053363
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    882.1310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ad-Tech Medical Instrument Corp
    Date Received
    December 2, 2005
    Decision Date
    May 30, 2006
    Product Code
    GYC
    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
    GYC Electrode, Cortical

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    Other Clearances by Ad-Tech Medical Instrument Corp

    K Number Device Name
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