K071057 is an FDA 510(k) clearance for the COLONIC & ENEMA NOZZLE. This device is classified as a Colonic Irrigation System (Class II - Special Controls, product code KPL).
Submitted by Tiller Mind Body, Inc. (The Woodlands, US). The FDA issued a Cleared decision on October 5, 2007, 172 days after receiving the submission on April 16, 2007.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5220.
| 510(k) Number | K071057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2007 |
| Decision Date | October 05, 2007 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPL — Colonic Irrigation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5220 |