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510(k) Data Aggregation
K Number
K150381Device Name
AQUA CLEANSE
Manufacturer
QUALITY MEDICAL SUPPLY, INC
Date Cleared
2015-09-11
(205 days)
Product Code
KPL
Regulation Number
876.5220Why 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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