K220586 is an FDA 510(k) clearance for the Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).
Submitted by Sofradim Production (Trévoux, FR). The FDA issued a Cleared decision on June 22, 2022, 113 days after receiving the submission on March 1, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K220586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2022 |
| Decision Date | June 22, 2022 |
| Days to Decision | 113 days |
| Submission Type | Special |
| 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 |