Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K202087
    Device Name
    DIXI Medical Microdeep Micro-Macro Depth Electrodes
    Manufacturer
    Dixi Medical
    Date Cleared
    2021-11-18

    (478 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dixi Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DIXI Medical Microdeep® Micro-Macro Depth Electrodes are intended for temporary (<30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of epileptogenic foci and brain mapping.
    Device Description
    The Microdeep® Micro-Macro Depth Electrode is a single patient use, sterile and disposable device. The Microdeep® Micro-Macro Depth Electrode is invasive as it is placed in contact with nerve tissue (brain) and must only be used during an SEEG procedure with Anchor Bolts. The Microdeen® Micro-Macro Depth Electrode is intended to connect to the user's recording. monitoring and stimulation equipment using the Connection System. This product is intended to be used only by physicians in the area of biopotential recording, monitoring and stimulation / response studies who are trained in intracranial neurophysiology. The DIXI Medical Microdeep® Micro-Macro Depth Electrode is comprised of the following components: Macro-contacts, Micro-contacts, Microdrive for micro-contacts, Cap, Connectors for micro and macro-contacts.
    Ask a Question
    K Number
    K201931
    Device Name
    Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
    Manufacturer
    Dixi Medical
    Date Cleared
    2021-10-02

    (446 days)

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

    Dixi Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DIXI Medical Intraoperative Subdural Electrodes (Strips and Grids) are intended for intraoperative use for less than or equal to 24 hours with recording and stimulation equipment for the recording and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports brain mapping.
    Device Description
    The DIXI Medical Intraoperative Subdural Electrode (Strips and Grids) is an intra-cranial electrode used intraoperatively on the surface of the brain. The device is designed for electroencephalography (EEG) recording and brief stimulation for brain mapping purposes. The DIXI Medical Intraoperative Subdural Electrode consists of circular contacts sandwiched between two layers of silicone substrate. The brain contacting side of the silicone substrate body has material removed to expose an amount of contact surface area. Insulated wires extend from each contact through a flexible tube which terminates in connectors for direct connection to user's equipment.
    Ask a Question
    K Number
    K170959
    Device Name
    DIXI Medical Microdeep Depth Electrode
    Manufacturer
    DIXI Medical
    Date Cleared
    2017-11-24

    (238 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIXI Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DIXI Medical Microdeep Depth Electrodes are intended for temporary (<30 day) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
    Device Description
    The DIXI Medical Microdeep Depth Electrode ("Microdeep Depth Electrode" or "Electrode") is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. Microdeep Depth Electrodes are used under the supervision of a physician (physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of depth electrodes) and are intended to connect to the user's recording, monitoring and stimulation equipment. This information is then used for defining the location of epileptogenic foci and brain mapping.
    Ask a Question

    Page 1 of 1