KPL · Colonic Irrigation System
Gastroenterology, Urology · 21 CFR 876.5220 · Class 2
Overview
| Product Code | KPL |
|---|---|
| Device Name | Colonic Irrigation System |
| Regulation | 21 CFR 876.5220 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A 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 pressure, temperature, or flow of water through the nozzle to be controlled. The device may include a console-type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. The device may use electrical power to heat the water. The device does not include the enema kit (§ 876.5210).
Classification Rationale
(1) Class II (performance standards) when the device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.(2) Class III (premarket approval) when the device is intended for other uses, including colon cleansing routinely for general well being.
Recent Cleared Devices (20 of 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201861 | Bio Fluff System | Gnali Bocia S.R.L. | Mar 2, 2022 | SESE |
| K180800 | Colonic Plus Regular, Small, and Straight Shape Hydrokit | Colonic Plus | Jun 1, 2018 | SESK |
| K152834 | Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 | Colonplus Equipments & Speculums, S.L. | Aug 10, 2016 | SESE |
| K150381 | AQUA CLEANSE | Quality Medical Supply, Inc. | Sep 11, 2015 | SESE |
| K131852 | HC-1 AND HC-1 CLASSIC | Transcendencias Comerciales SL Transcom | Apr 17, 2014 | SESE |
| K094022 | THE WATER LILY | Clearwater Products, LLC | Jun 11, 2010 | SESE |
| K071057 | COLONIC & ENEMA NOZZLE | Tiller Mind Body, Inc. | Oct 5, 2007 | SESE |
| K051344 | COLONIC AND ENEMA NOZZLE | Ultimate Concepts, Inc. | Aug 18, 2005 | SESE |
| K050992 | CONMED IRRIGATION NOZZLE | Conmedcorp | Jul 14, 2005 | SESE |
| K050112 | PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 | Prime Pacific Health Innovations Corporation | Mar 15, 2005 | SESE |
| K033149 | ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM | Ultimate Concepts, Inc. | Mar 23, 2004 | SESE |
| K003720 | ANGEL OF WATER COLON HYDROTHERAPY SYSTEM | Lifestream Purfication Systems, LLC | Jun 27, 2002 | SESE |
| K002102 | GENTLE COLONICS IRRIGATION SYSTEM | Gentle Colonics, Inc. | Feb 6, 2002 | SESE |
| K000031 | AQUANET, MODEL EC 2000 | Prime Pacific Health Innovations Corporation | Sep 10, 2001 | SESE |
| K000388 | CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) | Clearwater Colon Hydrotherapy, Inc. | Aug 8, 2000 | SESE |
| K980868 | GC IRRIGATOR | Gentle Colonics, Inc. | Aug 6, 1998 | SESE |
| K970482 | TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 | Srs Intl. | Oct 31, 1997 | SESE |
| K973256 | JIMMY JOHN III RECTAL NOZZLE | Colon Therapeutics | Sep 29, 1997 | SESE |
| K972455 | JIMMY JOHN III RECTAL NOZZEL, MODEL CIT | Colon Therapeutics | Sep 9, 1997 | SESE |
| K962259 | LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE) | Tiller Mind Body, Inc. | Aug 29, 1996 | SESE |
Top Applicants
- Colon Therapeutics — 8 clearances
- Tiller Mind Body, Inc. — 3 clearances
- Clearwater Colon Hydrotherapy, Inc. — 2 clearances
- Gentle Colonics, Inc. — 2 clearances
- Prime Pacific Health Innovations Corporation — 2 clearances
