K112342 is an FDA 510(k) clearance for the FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Convatec, Inc. (Skillman, US). The FDA issued a Cleared decision on April 26, 2012, 255 days after receiving the submission on August 15, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K112342 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2011 |
| Decision Date | April 26, 2012 |
| Days to Decision | 255 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 |