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510(k) Data Aggregation

    K Number
    K990572
    Device Name
    SONOTOME
    Manufacturer
    SONOKINETICS, INC.
    Date Cleared
    1999-05-21

    (87 days)

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

    SONOKINETICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SONOTOME System is intended for the following indications: Breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic.
    Device Description
    The SONOTOMETM System contains three subsystems: ultrasonic energy, irrigation and aspiration. The SONOTOME™ System uses a hollow titanium tip PROBE mounted to a reusable handpiece. The ultrasonic power generator provides energy to the handle which converts it into ultrasonic energy at the tip. The irrigation and the ultrasonic energy are activated by depressing the foot pedal. The vibrating probe mounted on the hand piece is then applied to the tissue desired to be removed. The application of ultrasonic energy through the tip breaks down the tissue through a cavitation action. The resultant debris is aspirated through the probe tip and into a disposable trap between the handpiece and the vacuum canister. The flow of saline is maintained to reduce the temperature of the probe and to provide for a means of irrigation to the surgical site.
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