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510(k) Data Aggregation

    K Number
    K961113
    Device Name
    CNS INTERCHANGEABLE BIT CRANIAL DRILL
    Manufacturer
    CLINICAL NEURO SYSTEMS LLC.
    Date Cleared
    1996-06-05

    (77 days)

    Product Code
    HBG
    Regulation Number
    882.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINICAL NEURO SYSTEMS LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The drill is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP. The drill is intended for single use only.
    Device Description
    Clinical Neuro Systems Interchangeable Bit Cranial Drill consists of various bit sizes used during a ventriculostomy procedure. The product includes a hand drill with variable chuck, a 0.156" (3.97mm) drill bit with depth guard, a 0.209" (5.31mm) drill bit with depth guard, and a 0.25" (6.35mm) drill bit with depth guard. The depth quard allows accurate, secure, and easy to use adjustment of cranial drill depth. Cranial drill depth is selected by setting the depth guard to the required distance. The Cranial Drill allows for access to the subarachnoid space or the lateral ventricles of the brain. The Cranial Drill is supplied sterile, double CSR wrapped in a Chevron pouch.
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