Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K190281
    Device Name
    Ultrasonic Surgical System
    Manufacturer
    MediSonic Technology Co
    Date Cleared
    2019-10-31

    (262 days)

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

    MediSonic Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultrasonic System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone. osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: - · Otolaryngology - Oral/maxillofacial - · Hand and foot - · Neurosurgery - · Spine - · Plastic/reconstructive.
    Device Description
    Ultrasonic Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of tip inserts, a torque wrench, a footswitch, and an irrigation set (liquid-flow tube and liquid-flow sleeve). The console has a touch panel that allows the surgeon to control device operation. The console activates and controls the ultrasound vibration, controls irrigation flow, and displays system condition. Inside the console are located the ultrasonic generator, the electrical power supply module, and the micro-processor electronic board that controls and supervises the functional parameters of the device. The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are activated by pressing the footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece. Ultrasonic Surgical System uses ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the tip insert. The tips are used to fragment and reshape bone and soft tissue through longitudinal and (for bone drilling) rotational vibration at high frequency and small amplitude, while keeping the soft tissues with elastic properties free of damage. Ultrasonic Surgical System comes with separate handpieces for Ultrasonic Surgical Bone Cutting and Ultrasonic Surgical Bone Drilling. The handpieces are reprocessed through cleaning and disinfection before each use. The ultrasonic tips, irrigation tubing, and water injection sleeves are provided sterile for single use.
    Ask a Question

    Page 1 of 1