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 | October 24, 2025 |
| K251955 | davol inc., subsidiary of c. r. bard | Onflex Mesh | July 24, 2025 |
| K251557 | davol | Bard® Mesh; Bard® Mesh Pre-Shaped | June 12, 2025 |
| K250869 | sofradim production | Parietene Macroporous Mesh (PPM5050 ) | April 23, 2025 |
| K250098 | davol | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | April 9, 2025 |
| K243315 | sofradim production | ProGrip Self-Gripping Polypropylene Mesh | January 17, 2025 |
| K241250 | davol inc., subsidiary of c. r. bard | 3DMax Light Mesh | June 14, 2024 |
| K232373 | sofradim production | Progrip Self-Gripping Polypropylene Mesh | January 18, 2024 |
| K233402 | davol inc., subsidiary of c. r. bard | Bard 3DMax Mesh | November 1, 2023 |
| K232924 | deep blue medical advances | T-Line® Hernia Mesh | October 18, 2023 |
| K230671 | xiros | Pitch PaSoft Tissue Reinforcement Device | May 31, 2023 |
| K230227 | deep blue medical advances | T-Line Hernia Mesh | February 23, 2023 |
| K223218 | sofradim production | Parietene Macroporous Mesh | December 2, 2022 |
| K221556 | deep blue medical advances | T-Line Hernia Mesh | November 28, 2022 |
| K220540 | covidien | ProGrip Self-Gripping Polypropylene Mesh | September 22, 2022 |
| K220091 | xiros | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | August 26, 2022 |
| K220586 | sofradim production | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophi | June 22, 2022 |
| K211132 | ariste medical | ARISTE AB Mesh | March 18, 2022 |
| K211563 | xiros | Pitch-Patchs | August 13, 2021 |