K110581 is an FDA 510(k) clearance for the PROPATCH SOFT TISSUE REPAIR MATRIX, a Mesh, Surgical (Class II — Special Controls, product code FTM), submitted by Cryolife, Inc. (Kennesaw, US). The FDA issued a Cleared decision on January 10, 2012, 315 days after receiving the submission on March 1, 2011. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K110581 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 01, 2011 |
| Decision Date | January 10, 2012 |
| Days to Decision | 315 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTM — Mesh, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |