K192389 is an FDA 510(k) clearance for the TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large). This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).
Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on March 27, 2020, 206 days after receiving the submission on September 3, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K192389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2019 |
| Decision Date | March 27, 2020 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTL — Mesh, Surgical, Polymeric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |