K193325 is an FDA 510(k) clearance for the Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Prosys International, Ltd. (Wimbledon, GB). The FDA issued a Cleared decision on March 13, 2020, 102 days after receiving the submission on December 2, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K193325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2019 |
| Decision Date | March 13, 2020 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT - Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |