Colonic Irrigation System
Gastroenterology, Urology · 21 CFR 876.5220
Recent MDR events
16 adverse event reports on file
- ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEMJan 3, 2017InjuryLifestream Purification Systems, Llc3003860916-2016-00001
- LIBBEJan 25, 2013OtherTiller Mind Body, Inc.1648139-2013-00001
- ANGEL OF WATER COLON IRRIGATION SYSTEMDec 23, 2010OtherLifestream Purification Systems, Llc3003860916-2010-00002
- ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEMAug 12, 2010OtherLifestream Purification Systems, Llc3003860916-2009-00001
- ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEMSep 18, 2007OtherLifestream Purification Systems, Llc3003860916-2007-00002
- ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEMMar 7, 2007InjuryLifestream Purification Systems, Llc3003860916-2007-00001
- ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEMNov 30, 2006OtherLifestream Purification Systems, Llc3003860916-2006-00001
- JIMMY JOHN IIIOct 28, 2003OtherColon Therapeutics Inc.1640200-2003-00003
- LIBBE COLON HYDROTHERAPY DEVICEOct 14, 2003OtherTiller Mind Body, Inc.1648139-2003-00002
- LIBBE COLON HYDROTHERAPY DEVICEOct 9, 2003OtherTiller Mind Body, Inc.1648139-2003-00003
Event type breakdown
Registered firms
16 firms currently registered for this product code
Specialty Health Products, Llc.
Phoenix, AZ, US
Conmed Corporation
Utica, NY, US
Oman Medical Beauty Manufacture Limited
Hong Kong, HK
Hebei Mita Biotechnology Limited
Hong Kong, HK
Clearwater Colon Hydrotherapy, Inc.
OCALA, FL, US
Gorgeous Beauty Equipment Manufacture Limited
Hong Kong, HK
Transcendencias Comerciales S.l
Ergobia-Astigarraga Guipuzcoa, ES
Conmed Corporation
WESTBOROUGH, MA, US
Prime Pacific Health Innovations Corporation
PORT COQUITLAM British Columbia, CA
Hebei Mita Technology Limited
Hong Kong, HK
Tiller Mind Body, Inc.
San Antonio, TX, US
Consolidated Medical Equipment Company
Chihuahua, MX
Busse Hospital Disposables
HAUPPAUGE, NY, US
510(k) clearances
40 clearances for this product code
- Gnali Bocia S.R.L.Mar 2, 2022
K201861 · Bio Fluff System
- Colonic PlusJun 1, 2018
K180800 · Colonic Plus Regular, Small, and Straight Shape Hydrokit
- Colonplus Equipments & Speculums, S.L.Aug 10, 2016
K152834 · Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
- Quality Medical Supply, Inc.Sep 11, 2015
K150381 · AQUA CLEANSE
- Transcendencias Comerciales SL TranscomApr 17, 2014
K131852 · HC-1 AND HC-1 CLASSIC
- Clearwater Products, LLCJun 11, 2010
K094022 · THE WATER LILY
- Tiller Mind Body, Inc.Oct 5, 2007
K071057 · COLONIC & ENEMA NOZZLE
- Ultimate Concepts, Inc.Aug 18, 2005
K051344 · COLONIC AND ENEMA NOZZLE