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510(k) Data Aggregation

    K Number
    K023288
    Device Name
    COBRA BIPOLAR CLAMP, MODEL 15902
    Manufacturer
    BOSTON SCIENTIFIC EP TECHNOLOGIES
    Date Cleared
    2003-04-02

    (182 days)

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

    BOSTON SCIENTIFIC EP TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cobra Bipolar System (System) is intended for the coagulation of soft tissue during general surgery. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
    Device Description
    The Cobra Bipolar System device is comprised of two components; a reusable surgical clamp and an associated coagulating device BSC/ EP Technologies has named the Cobra Bipolar Insert. The Bipolar Insert is a sterile, single use device that transmits radiofrequency (RF) energy to coagulate soft tissues. The Bipolar Clamp will be used with a Cobra Electrosurgical Unit (ESU). The ESU delivers 460 kHz RF energy to selected Bipolar Clamp electrodes, modulates the RF energy to keep all selected Bipolar Clamp electrodes' temperatures essentially the same, and adjusts the power output to maintain the maximum temperature of all selected electrodes close to the set point.
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