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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    FLASH EVD System (10-0002)

    K Number: K242480 · Decision Dec 27, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    1
    Review Days
    128

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    Basic Information

    Device Name
    FLASH EVD System (10-0002)
    K Number
    K242480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    7D Surgical ULC
    Date Received
    August 21, 2024
    Decision Date
    December 27, 2024
    Product Code
    HAW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HAW Neurological Stereotaxic Instrument

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