The following data is part of a premarket notification filed by Covidien with the FDA for Progrip Self-gripping Polypropylene Mesh.
| Device ID | K220540 |
| 510k Number | K220540 |
| Device Name: | ProGrip Self-Gripping Polypropylene Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Covidien 15 Hampshire Street Mansfield, MA 02048 |
| Contact | Jonas Gulmez |
| Correspondent | Jonas Gulmez Covidien 15 Hampshire Street Mansfield, MA 02048 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-25 |
| Decision Date | 2022-09-22 |