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    K Number
    K092156
    Device Name
    CAD 12, COLONOSCOPY ASSIST DEVICE
    Manufacturer
    SOFTSCOPE MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2009-10-14

    (90 days)

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

    SOFTSCOPE MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAD 12 is indicated for use with a flexible endoscope to aid endoscopic insertion and advancement during diagnostic and therapeutic lower gastrointestinal endoscopy.
    Device Description
    The CAD 12 is an endoscopic accessory device configured as an overtube to aid insertion and advancement of an endoscope. The CAD 12 utilizes a rotating membrane tube to advance the endoscope in the lower GI tract. The rotating membrane tube is driven by two mechanical rotating drive wires.
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