K941279 is an FDA 510(k) clearance for the LOWER BOWEL EVACUATION SYSTEM. This device is classified as a Colonic Irrigation System (Class II - Special Controls, product code KPL).
Submitted by Tiller Mind Body, Inc. (San Antonio, US). The FDA issued a Cleared decision on October 12, 1995, 575 days after receiving the submission on March 16, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5220.
| 510(k) Number | K941279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 1994 |
| Decision Date | October 12, 1995 |
| Days to Decision | 575 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KPL — Colonic Irrigation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5220 |