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510(k) Data Aggregation
K Number
K051344Device Name
COLONIC AND ENEMA NOZZLE
Manufacturer
ULTIMATE CONCEPTS, INC.
Date Cleared
2005-08-18
(87 days)
Product Code
KPL
Regulation Number
876.5220Why did this record match?
Applicant Name (Manufacturer) :
ULTIMATE CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Colonic Nozzle is to be used as an attachment to gravity fed colonic systems for cleansing when medically indicated such as before radiological or endoscopic examination.
Device Description
This Colonic nozzle is made of medical grade tubing, has an opening on one end. The other end is sealed with a small hole in the middle and has two holes on the sides at the same end.
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K Number
K033149Device Name
ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM
Manufacturer
ULTIMATE CONCEPTS, INC.
Date Cleared
2004-03-23
(175 days)
Product Code
KPL
Regulation Number
876.5220Why did this record match?
Applicant Name (Manufacturer) :
ULTIMATE CONCEPTS, 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 examinations.
Device Description
This colonic irrigation system is a device intended to instill water into the colon through a nozzle inserted into the rectum to cleanse (evacuate) the contents of the lower colon. The system is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigation. The device consists of a container for fluid connected to the nozzle via tubing and includes a system which enables the temperature, and gravity induced flow of water through the nozzle to be controlled. The device includes a console-type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. This device uses water that comes from household type hot and cold outlets.
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