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510(k) Data Aggregation

    K Number
    K964111
    Device Name
    LITHOVAC SUCTION/ASPIRATION PROBE
    Manufacturer
    ELECTRO MEDICAL SYSTEMS SA
    Date Cleared
    1996-12-16

    (62 days)

    Product Code
    KQT
    Regulation Number
    876.4370
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    Product Code :

    KQT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electro Medical Systems SA LITHOVAC Suction/Aspiration Probe is designed for the suction and aspiration of urinary tract calculi fragments through rigid or semi-rigid endoscopes. It can be used alone, or it can be used during and after fragmentation of urinary tract calculi with the EMS Swiss LITHOCLAST intracorporeal lithotripter. It is specifically designed so that an EMS LITHOCLAST lithotripsy probe can be inserted through the LITHOVAC suction tube so that stone fragments and debris can be aspirated through the LITHOVAC suction tube simultaneously with lithotripsy.
    Device Description
    The EMS SA LITHOVAC Suction/Aspiration Probe is intended to be used to aspirate out urinary calculi. fragments and debris using a standard vacuum source, i.e. a regulated wall vacuum, a standard suction pump, or a peristaltic pump which can supply up to -0.8 bar vacuum. Accessory adapters are provided to permit it to be used to aspirate urinary stone fragments or debris produce during fragmentation of urinary stones with the EMS Swiss LITHOCLAST lithotripter. The LITHOVAC consists of a suction tube with a trumpet valve, and accessories for connecting the EMS Swiss LITHOCLAST handpiece and probe to the suction tube. The LITHOVAC suction tube is made of type 304 stainless steel and is available in four diameter/length combinations as follows: - 1.6 mm OD/445 mm length disposable sterile . - 1.6 mm OD/555 mm length disposable sterile . - 3.5 mm OD/460 mm length reusable non-sterile . - 4 mm OD/430 mm length reusable non-sterile ● The size of the suction tube is chosen according to the size of the endoscope to be used, e.g., the 4 mm LITHOVAC Probe is used through a 12 Fr or greater endoscope.
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