K101587 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 September 16, 2010, 101 days after receiving the submission on June 7, 2010. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K101587 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 07, 2010 |
| Decision Date | September 16, 2010 |
| Days to Decision | 101 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 |