K150381 is an FDA 510(k) clearance for the AQUA CLEANSE. This device is classified as a Colonic Irrigation System (Class II — Special Controls, product code KPL).
Submitted by Quality Medical Supply, Inc. (Surprise, US). The FDA issued a Cleared decision on September 11, 2015, 205 days after receiving the submission on February 18, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5220.
| 510(k) Number | K150381 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 18, 2015 |
| Decision Date | September 11, 2015 |
| Days to Decision | 205 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 |