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510(k) Data Aggregation

    K Number
    K980895
    Device Name
    ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR
    Date Cleared
    1998-11-06

    (242 days)

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

    **CALIFORNIA INSTITUTE OF TISSUE ENG. **& INSTRUMENTI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Allegro is indicated for use in the following surgical specialties when the fragmentation, emulsification and aspiration of soft tissue is desired. -General Surgery -Plastic and reconstructive Surgery
    Device Description
    The Allegro is comprised of a power conditioner (110/120 volts AC), a microcomputer, a control panel, a signal generator, a BNC output, and a separate surgical handpiece. The power conditioner serves to buffer the system from commercial electrical discontinuities and provides a continuous electrical signal to Allegro's components. The microcomputer integrates Allegro's system components and provides a user-friendly control interface. The control panel provides for user input and system settings and displays. The signal generator creates electrical current in programmable waveforms (20-25 kHz). The BNC output connects the system to the surgical handpiece. The surgical handpiece contains the electromotive engine (piezoelectric ceramic stack), the infiltration/aspiration port, and the ultrasonic surgical probe. The electrical waveforms sent to the handpiece excite the motor stack and cause high-frequency, small amplitude motion of the ultrasonic surgical probe. Motion at the tip of the probe fragments local soft tissue, which is then aspirated through the probe.
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