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510(k) Data Aggregation

    K Number
    K143662
    Device Name
    Bissinger Monopolar Forceps and Cables
    Manufacturer
    Date Cleared
    2015-03-12

    (79 days)

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

    MEDAGENT, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The monopolar forceps and clamps are designed to grasp, dissect and coagulate tissue. They must be connected to the monopolar output of an electrosurgical generator and must only be used with parameters for monopolar coagulation. Do not exceed a maximum output of 2000 Vp of your generator. Cables for electrosurgery are designed to conduct electrical power from the output of a high-frequency electrosurgical generator to the electrosurgical instrument. Do not exceed a maximum output of 6250 Vp of your generator.
    Device Description
    Bissinger's Monopolar Forceps are used in various surgical applications. Therefore they are varying in size and build-up, though the general principle remains unchanged. By using the firmly attached connecting cable, the monopolar forceps can be connected to high-frequency electrosurgical generators. Monopolar Forceps are used for grasping, dressing and coagulating of tissue. They must be connected to a monopolar output of a high frequency generator by using the attached monopolar cable. The application of monopolar current and connection with a neutral electrode is mandatory. Bissinger's monopolar forceps either have a straight or bayonet-shaped handle. They are equipped with a firmly attached connecting cable with dual spring connector. Bissinger Cables are a line of non-sterile, reusable Monopolar Cables fitting Erbe, Martin, Berchtold, Bovie, Valleylab, Codmann Electrosurgical units. They are designed to conduct electrical power from the output of a high frequency generator to the instrument.
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