FTL — Mesh, Surgical, Polymeric Class II
FDA product code FTL covers "Mesh, Surgical, Polymeric", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FTL
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253956 | Sofradim Production | ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, A | May 21, 2026 |
| K253125 | Medtronic - Sofradim Production | Parietene Flat Sheet Mesh | Oct 24, 2025 |
| K251955 | Davol Inc., Subsidiary Of C. R. Bard | Onflex Mesh | Jul 24, 2025 |
| K251557 | Davol | Bard® Mesh; Bard® Mesh Pre-Shaped | Jun 12, 2025 |
| K250869 | Sofradim Production | Parietene Macroporous Mesh (PPM5050 ) | Apr 23, 2025 |
| K250098 | Davol | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | Apr 9, 2025 |
| K243315 | Sofradim Production | ProGrip Self-Gripping Polypropylene Mesh | Jan 17, 2025 |
| K241250 | Davol Inc., Subsidiary Of C. R. Bard | 3DMax Light Mesh | Jun 14, 2024 |
| K232373 | Sofradim Production | Progrip Self-Gripping Polypropylene Mesh | Jan 18, 2024 |
| K233402 | Davol Inc., Subsidiary Of C. R. Bard | Bard 3DMax Mesh | Nov 1, 2023 |
| K232924 | Deep Blue Medical Advances | T-Line® Hernia Mesh | Oct 18, 2023 |
| K230671 | Xiros | Pitch PaSoft Tissue Reinforcement Device | May 31, 2023 |
| K230227 | Deep Blue Medical Advances | T-Line Hernia Mesh | Feb 23, 2023 |
| K223218 | Sofradim Production | Parietene Macroporous Mesh | Dec 2, 2022 |
| K221556 | Deep Blue Medical Advances | T-Line Hernia Mesh | Nov 28, 2022 |
| K220540 | Covidien | ProGrip Self-Gripping Polypropylene Mesh | Sep 22, 2022 |
| K220091 | Xiros | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Aug 26, 2022 |
| K220586 | Sofradim Production | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophi | Jun 22, 2022 |
| K211132 | Ariste Medical | ARISTE AB Mesh | Mar 18, 2022 |
| K211563 | Xiros | Pitch-Patchs | Aug 13, 2021 |