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510(k) Data Aggregation

    K Number
    K082505
    Device Name
    KLS MARTIN ELECTROSURGICAL INSTRUMENTS
    Manufacturer
    Date Cleared
    2009-06-12

    (287 days)

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

    KL MARTIN L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    KLS Martin Bipolar Scissors are intended for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures. KLS Martin Bipolar Instruments with Handles and Exchangeable Electrodes are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures. KLS Martin marLap Bipolar Coagulation instruments are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures. KLS Martin Bipolar Forceps/Non-Stick are design to grasp, manipulate and coagulate selected tissue. KLS Martin Electrosurgical Instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures KLS Martin Electrosurgical cables are intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar electrosurgical generator to a bipolar instrument.
    Device Description
    The KLS Martin Electrosurgical Instruments are surgical instruments that allow the surgeon to cauterize and coagulate tissue by passing a electrical current that is provided by a electrosurgical generator. The instruments are insulated to isolate the user from the current. The KLS Martin Electrosurgical Instruments are manufactured in a variety of shapes and sizes to allow the operating surgeon choices for optimum efficiency.
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