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510(k) Data Aggregation

    K Number
    K060182
    Device Name
    TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE
    Manufacturer
    AUSTRALIAN SURGICAL DEVICES
    Date Cleared
    2006-09-07

    (226 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUSTRALIAN SURGICAL DEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ASD-Tactile™ Suction and Irrigation System is a sterile, single-use device indicated for use in patients undergoing general laparoscopic surgical procedures.
    Device Description
    The ASD Tactile Suction and Irrigation System, SI-3000TY and SI-3000TY and SI-3000TYR, is indicated for use in patients undergoing general laparoscopic surgical procedures. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site. The ASD Tactile Suction and Irrigation System consists of a handpiece equipped with 2 trumpet style valves, a stainless steel probe, and 2 connecting lines of tubing, one designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure. The handpiece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments, diameter sizes ranging from 2mm to 5mm to pass through without either a loss of pneumoperitoneum or leakage of fluid. A probe is attached to the handpiece via a threaded connector, thus allowing different sized probes to be attached to the handpiece during surgery. The suction irrigator is a single use disposable device and is sold sterile.
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