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510(k) Data Aggregation

    K Number
    K242480
    Device Name
    FLASH EVD System (10-0002)
    Manufacturer
    7D Surgical ULC
    Date Cleared
    2024-12-27

    (128 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    7D Surgical ULC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FLASH EVD is a stereotactic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments. The device is only indicated for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient.
    Device Description
    FLASH EVD System is a stereotactic image guided surgical navigation system during cranial procedures. The FLASH EVD software assists in guiding surgeons during external ventricular drainage (EVD) catheter placement procedure, also known as a ventriculostomy, is prescribed to relieve elevated intracranial pressure when there is a disruption in the normal flow of cerebrospinal fluid (CSF) within the brain.
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