K201861 is an FDA 510(k) clearance for the Bio Fluff System. This device is classified as a Colonic Irrigation System (Class II - Special Controls, product code KPL).
Submitted by Gnali Bocia S.R.L. (Lumezzane, IT). The FDA issued a Cleared decision on March 2, 2022, 604 days after receiving the submission on July 6, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5220.
| 510(k) Number | K201861 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2020 |
| Decision Date | March 02, 2022 |
| Days to Decision | 604 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 |