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510(k) Data Aggregation

    K Number
    K210942
    Device Name
    MicroFrance Monopolar and Bipolar Electrosurgical Instruments
    Date Cleared
    2021-05-14

    (45 days)

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

    Integra MicroFrance

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The electrosurgical instruments are intended to remove tissue and/or control bleeding.
    Device Description
    The MicroFrance® Bipolar and Monopolar Electrosurgical Instruments consist of forceps, probes, knives, suction tubes, hooks, elevators and picks used for laparoscopic access and open surgery. These electrosurgical instruments are reusable and available in unibody (one-piece) and dismantlable (modular) designs. They are used as part of an electrosurgical system consisting of a generator and cord attached to the proximal end of the devices to provide power and deliver electrical current from the generator to the distal tips of the devices.
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