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510(k) Data Aggregation

    K Number
    K072870
    Device Name
    MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)
    Manufacturer
    FOUNDRY NEWCO X, INC.
    Date Cleared
    2008-01-14

    (97 days)

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

    FOUNDRY NEWCO X, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microwave Tissue Coagulation System (MTCS) is intended for coagulation of soft tissue.
    Device Description
    The Microwave Tissue Coagulation System (MTCS) is designed to coagulate soft tissue using a surface contact applicator. The system consists of an applicator, external microwave generator, vacuum pump, and a cooling fluid pump and tubing. The desired power and delivery time are set manually by the operator. The generator contains electric circuits, circuit boards, and integrated control panel. The major components of the generator are cooling fans, power supply, microwave module and the front panel/control board assembly. The applicator is a specifically designed to deliver microwave energy at the frequency and power levels that the generator outputs. The proximal end of the applicator has a microwave connector that fits onto the generator and allows the energy to be delivered to the applicator.
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