K094022 is an FDA 510(k) clearance for the THE WATER LILY. This device is classified as a Colonic Irrigation System (Class II - Special Controls, product code KPL).
Submitted by Clearwater Products, LLC (Crofton, US). The FDA issued a Cleared decision on June 11, 2010, 163 days after receiving the submission on December 30, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5220.
| 510(k) Number | K094022 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2009 |
| Decision Date | June 11, 2010 |
| Days to Decision | 163 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 |