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

    SmartFlow Neuro Cannula

    K Number: DEN240023 · Decision Nov 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    12
    Review Days
    175

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    Basic Information

    Device Name
    SmartFlow Neuro Cannula
    K Number
    DEN240023
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.4110
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    ClearPoint Neuro, Inc.
    Date Received
    May 22, 2024
    Decision Date
    November 13, 2024
    Product Code
    SDG
    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
    SDG Brain Intraparenchymal Infusion Cannula

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