K152834 is an FDA 510(k) clearance for the Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10. This device is classified as a Colonic Irrigation System (Class II - Special Controls, product code KPL).
Submitted by Colonplus Equipments & Speculums, S.L. (San Sebastian (Guipuzcoa), ES). The FDA issued a Cleared decision on August 10, 2016, 316 days after receiving the submission on September 29, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5220.
| 510(k) Number | K152834 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2015 |
| Decision Date | August 10, 2016 |
| Days to Decision | 316 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 |