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510(k) Data Aggregation

    K Number
    K211954
    Device Name
    Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
    Manufacturer
    Spes Medica SRL
    Date Cleared
    2022-11-10

    (505 days)

    Product Code
    GYC
    Regulation Number
    882.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    Spes Medica SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Recording and stimulating for Central Nervous System electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for limited (≤24 hours) use with recording, monitoring, and stimulation equipment for electrical stimulation, monitoring of the signals on the surface of the brain for intraoperative monitoring, brain mapping and location of epileptogenic foci.
    Device Description
    The Recording and stimulating for Central Nervous System electrodes are used for electrical stimulation, monitoring and recording of the signals on the surface of the brain for intraoperative monitoring, brain mapping and location of epileptogenic foci. The electrodes are multipole arrays of electrodes that are positioned on the surface of the brain. The electrode must be designed to follow the complex anatomy and they can assume different conformations in relation to the requests of clinical needs. The neurosurgeon is the person recommended for electrode placement. The electrodes have to be used under the direction of the neurosurgeon and other skilled physicians to support their clinical needs.
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