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510(k) Data Aggregation

    K Number
    K052035
    Device Name
    CANADY PLASMA PROBES
    Manufacturer
    CANADY TECHNOLOGY, LLC
    Date Cleared
    2005-08-31

    (34 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CANADY TECHNOLOGY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Canady Plasma Probes' intended use is for the delivery of argon gas plasma energy for argon enhanced coagulation of tissue.
    Device Description
    The Canady Plasma Probes are tubular instruments and are flexible. They are provided in various lengths and diameter sizes to accommodate the various size/types of endoscopes for a variety of applications (i.e. the treatment of various target tissues inside a patient). The Probes have applications in endoscopic surgical procedures such as upper and lower gastroenterology and bronchoscopy to provide a means of coagulation using electrosurgical current and argon gas. The device consists of a connector which acts also as a handle for maneuvering the probe inside the working channel of an endoscope. Via an inner lumen of the Canady Plasma Probe argon gas is delivered to the operative site as well as an internal wire to carry high frequency (HF) electrosurgical current to a tungsten electrode tip at the end of the tubing. A ceramic tip insulates the thermal plastic tubing from the heat generated during coagulation. The electrode is positioned in the ceramic tip such that it cannot contact the patient's tissue during coagulation procedure.
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