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

    CUSA Clarity Ultrasonic Surgical Aspirator System

    K Number: K230427 · Decision Jul 11, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    155
    Applicant Total
    7
    Review Days
    144

    Basic Information

    Device Name
    CUSA Clarity Ultrasonic Surgical Aspirator System
    K Number
    K230427
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra Lifesciences Corporation
    Date Received
    February 17, 2023
    Decision Date
    July 11, 2023
    Product Code
    LFL
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LFL Instrument, Ultrasonic Surgical

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