FTL
- Product code
- FTL
- Device name
- Mesh, Surgical, Polymeric
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 11
- Summaries archived here
- 10 (direct download)
- 510(k) clearances (all years, FDA)
- 336 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (11)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253956 | 2026-05-21 | Sofradim Production | ProGrip advanced self-gripping polypropylene mesh (… | |
| K253125 | 2025-10-24 | Medtronic - Sofradim Production | Parietene Flat Sheet Mesh | |
| K251955 | 2025-07-24 | Davol Inc., Subsidiary of C. R. Bard, … | Onflex Mesh | |
| K251557 | 2025-06-12 | Davol, Inc. | Bard® Mesh; Bard® Mesh Pre-Shaped | |
| K250869 | 2025-04-23 | Sofradim Production | Parietene Macroporous Mesh (PPM5050 ) | |
| K250098 | 2025-04-09 | Davol, Inc. | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | |
| K243315 | 2025-01-17 | Sofradim Production | ProGrip Self-Gripping Polypropylene Mesh | |
| K241250 | 2024-06-14 | Davol Inc., Subsidiary of C. R. Bard, … | 3DMax Light Mesh | |
| K232373 | 2024-01-18 | Sofradim Production | Progrip Self-Gripping Polypropylene Mesh | |
| K233402 | 2023-11-01 | Davol Inc., Subsidiary of C. R. Bard, … | Bard 3DMax Mesh | |
| K232924 | 2023-10-18 | Deep Blue Medical Advances, Inc. | T-Line® Hernia Mesh | FDA |
Official FDA classification page: FTL
Classification and pathway per current FDA publications. Data from openFDA (CC0).