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510(k) Data Aggregation

    K Number
    K012685
    Device Name
    REPROCESSED ENDOSCOPIC ELECTRODES
    Manufacturer
    Date Cleared
    2002-02-14

    (184 days)

    Product Code
    Regulation Number
    876.4300
    Why did this record match?
    Product Code :

    NLW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation and/or resection of soft tissue in the prostate and bladder as well as when ablation and coagulation are required in gynecological and urological surgical procedures.
    Device Description
    Reprocessed endoscopic electrodes are electrosurgical electrode devices that have a wide variety of tip configurations and sizes. The device is used to cut and cauterize prostate, bladder, gynecological, and urological tissue. They are used in conjunction with an endoscope and are powered by a separate RF generator. The RF generator component is not included in this submission; only the endoscopic electrodes are reprocessed.
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