FTL — Mesh, Surgical, Polymeric Class II
FDA Device Classification
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 |
|---|
| 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 |
| K200918 | mast biosurgery | SurgiWrap FROST | January 7, 2021 |