CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
Device Facts
| Record ID | K000388 |
|---|---|
| Device Name | CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) |
| Applicant | Clearwater Colon Hydrotherapy, Inc. |
| Product Code | KPL · Gastroenterology, Urology |
| Decision Date | Aug 8, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5220 |
| Device Class | Class 2 |
Regulatory Classification
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).
