K192615 is an FDA 510(k) clearance for the Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG). This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Synovis Life Technologies, Inc. (Baxter International Inc.) (St. Paul, US). The FDA issued a Cleared decision on December 17, 2019, 85 days after receiving the submission on September 23, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K192615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2019 |
| Decision Date | December 17, 2019 |
| Days to Decision | 85 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 |