FTL · Mesh, Surgical, Polymeric
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | FTL |
|---|---|
| Device Name | Mesh, Surgical, Polymeric |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 335)
Showing 20 most recent of 335 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253125 | Parietene Flat Sheet Mesh | Medtronic - Sofradim Production | Oct 24, 2025 | SESE |
| K251955 | Onflex Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | Jul 24, 2025 | SESE |
| K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped | Davol, Inc. | Jun 12, 2025 | SESE |
| K250869 | Parietene Macroporous Mesh (PPM5050 ) | Sofradim Production | Apr 23, 2025 | SESE |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | Davol, Inc. | Apr 9, 2025 | SESE |
| K243315 | ProGrip Self-Gripping Polypropylene Mesh | Sofradim Production | Jan 17, 2025 | SESE |
| K241250 | 3DMax Light Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | Jun 14, 2024 | SESE |
| K232373 | Progrip Self-Gripping Polypropylene Mesh | Sofradim Production | Jan 18, 2024 | SESE |
| K233402 | Bard 3DMax Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | Nov 1, 2023 | SESE |
| K232924 | T-Line® Hernia Mesh | Deep Blue Medical Advances, Inc. | Oct 18, 2023 | SESE |
| K230671 | Pitch PaSoft Tissue Reinforcement Device | Xiros, Ltd. | May 31, 2023 | SESE |
| K230227 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | Feb 23, 2023 | SESE |
| K223218 | Parietene Macroporous Mesh | Sofradim Production | Dec 2, 2022 | SESE |
| K221556 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | Nov 28, 2022 | SESE |
| K220540 | ProGrip Self-Gripping Polypropylene Mesh | Covidien | Sep 22, 2022 | SESE |
| K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | Aug 26, 2022 | SESE |
| K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh | Sofradim Production | Jun 22, 2022 | SESE |
| K211132 | ARISTE AB Mesh | Ariste Medical, LLC | Mar 18, 2022 | SESE |
| K211563 | Pitch-Patchs | Xiros, Ltd. | Aug 13, 2021 | SESE |
| K200918 | SurgiWrap FROST | Mast Biosurgery | Jan 7, 2021 | SESE |
Top Applicants
- W. L. Gore & Associates, Inc. — 36 clearances
- Sofradim Production — 35 clearances
- C.R. Bard, Inc. — 25 clearances
- ETHICON, Inc. — 24 clearances
- Atrium Medical Corp. — 11 clearances
