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510(k) Data Aggregation

    K Number
    K221123
    Device Name
    WISE Cortical Strip (WCS)
    Manufacturer
    WISE S.r.l.
    Date Cleared
    2022-11-22

    (218 days)

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

    WISE S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WISE Cortical Strip is intended for intraoperative (≤24 hours) use with recording, monitoring and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain. The WCS is indicated as an aid to IntraOperative Neurophysiological Monitoring (IONM) during brain surgeries.
    Device Description
    The WISE Cortical Strip is medical device composed of: - A strip containing 4 electrodes that is positioned during surgery on the exposed surface of the brain - A cable composed of 4 conductive channels intended to transfer electrical signals to and from a commercial connecting cable. The device is intended to be used only for intraoperative monitoring during brain surgery and is not implanted. The WCS is a sterile, single-use device, individually packaged with a shelf life of 18 months. Manufacture of the device uses a WISE proprietary patented technology called "Supersonic Cluster Beam Implantation" (SCBI). This technology produces flexible conductors by enabling thin conducting metal layers to be deposited on a silicone substrate. This enables the strip to be flexible and conform to the brain's surface. The WCS is intended to be used with FDA-cleared IONM equipment and a reusable connecting cable. The device does not include (as an accessory or component) these separate devices.
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