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510(k) Data Aggregation

    K Number
    K150381
    Device Name
    AQUA CLEANSE
    Manufacturer
    QUALITY MEDICAL SUPPLY, INC
    Date Cleared
    2015-09-11

    (205 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUALITY MEDICAL SUPPLY, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THIS DEVICE IS INTENDED FOR COLON CLEANSING WHEN MEDICALLY INDICATED. SUCH AS BEFORE RADIOLOGICAL OR ENDOSCOPIC EXAMINATION.
    Device Description
    The proposed device "Aqua Cleanse" is for colon cleansing when medically indicated such as before radiological or endoscopic examination. It introduces water at a comfortable temperature into the large intestine. It fills and empties water into and out of the colon thus cleansing it of its contents. The device is equipped with a pressure regulated safety system; a self-contained cleaning system, and flow regulator. lt is used with the accessory, disposable rectal speculum kits. The associated disposable kit is intended to introduce water into the colon through a speculum inserted into the rectum to assist with the evacuation of the contents of the lower colon. This is a single-use only kit.
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