NUB · Colonic Irrigation System, General Well Being
Gastroenterology, Urology · 21 CFR 876.5220 · Class 3
Overview
| Product Code | NUB |
|---|---|
| Device Name | Colonic Irrigation System, General Well Being |
| Regulation | 21 CFR 876.5220 |
| Device Class | Class 3 |
| 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.
Cleared Devices (0)
No cleared devices on record.
