BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ClearPoint System (Software Version 3.0)

    K Number: K243657 · Decision Jan 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    246
    Registration Numbers
    246
    Same Product Code
    417
    Applicant Total
    7
    Review Days
    58

    Basic Information

    Device Name
    ClearPoint System (Software Version 3.0)
    K Number
    K243657
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ClearPoint Neuro, Inc.
    Date Received
    November 27, 2024
    Decision Date
    January 24, 2025
    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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