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    K Number
    K021166
    Device Name
    ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
    Manufacturer
    ACMI-CIRCON CORPORATION
    Date Cleared
    2002-05-09

    (28 days)

    Product Code
    FDC
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACMI-CIRCON CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for use in patients requiring endoscopic surgery for general urological tissue resection, ablation, and excision and hemostasis of blood vessels. These procedures include Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resection, and Treatment of Vesical Neck Constriction.
    Device Description
    The USA Elite Bipolar Resectoscope consists of a Telescope, Sheath, Bipolar Working Element, and Obturator. The USA Elite Bipolar Resectoscope is designed to work with currently marketed Electrosurgery Systems consisting of a electrosurqical generator called the Controller, a disposable Bipolar Loop, and a reusable or disposable Loop Cable or Cord.
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