K213125 is an FDA 510(k) clearance for the PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Synovis Life Technologies. Inc. (A Subsidiary of Baxter (St. Paul, US). The FDA issued a Cleared decision on October 27, 2021, 30 days after receiving the submission on September 27, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K213125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2021 |
| Decision Date | October 27, 2021 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |