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510(k) Data Aggregation

    K Number
    K050161
    Device Name
    SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY
    Manufacturer
    CONMED ELECTROSURGERY
    Date Cleared
    2005-02-03

    (9 days)

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

    CONMED ELECTROSURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The System 7500® -B is used for the destruction of human tissue in surgical procedures to provide a therapeutic benefit. The ABCFlex™ Probe is intended for use with the System 7500® -B for non-contact superficial ablation and hemostasis through a flexible endoscope to the operative site.
    Device Description
    The System 7500 -B is an electrosurgical generator with Argon Beam Coagulation (ABC) capability. The basic modes of operation are conventional electrosurgical cutting, coagulation plus argon beam coagulation. When cutting, the edge of the electrode is drawn across the tissue while electrosurgical energy is being applied. When coagulating, the accessory electrode or argon beam may be held in contact with the tissue for desiccation or separated from the tissue by distance for fulguration to achieve the desired result. The ABCFlex™ Probe has 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 for delivering argon gas to the operative site as well as an internal cable 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 the coagulation procedure. Current and gas flow is controlled by the surgeon activating and deactivating a switching element part of the System 7500 -B ESU.
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