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510(k) Data Aggregation

    K Number
    K972148
    Device Name
    B.U.S. ENDOTRON
    Manufacturer
    Date Cleared
    1997-12-10

    (184 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAMAT S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medicamat B.U.S. Endotron® Ultrasonic Suction Unit is a classic ultrasonic scalpel, based on the principle of the breakdown and selective emulsification of tissue through cavitation. It utilizes the same fundamental principles as other ultrasonic surgical aspirators. The B.U.S. Endotron® is intended for use for general soft tissue removal in a variety of surgical applications, such as neurosurgery, hepatosurgery, general surgery, plastic and reconstructive surgery. The intended uses are the same as those for the predicate devices. Endotron® units are for use by skilled physicians who use them in accordance with procedures and practices taught in special medical training.
    Device Description
    The Medicamat B.U.S. Endotron® Ultrasonic Suction Unit is a classic ultrasonic scalpel, based on the principle of the breakdown and selective emulsification of tissue through cavitation. It utilizes the same fundamental principles as other ultrasonic surgical aspirators.
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