FDA product code FTL: Mesh, Surgical, Polymeric
FTL is the FDA product code for mesh, surgical, polymeric. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 336 510(k) submissions under FTL, 19 in the last five years, from 121 different applicants. The average 510(k) review took 118 days (median 89); 104 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 73 recalls for FTL devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Polymeric |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for FTL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 6 | 145 |
| 2018 | 12 | 123 |
| 2019 | 4 | 101 |
| 2020 | 5 | 150 |
| 2021 | 2 | 180 |
| 2022 | 6 | 185 |
| 2023 | 4 | 42 |
| 2024 | 2 | 102 |
| 2025 | 6 | 47 |
| 2026 | 1 | 162 |
Compare with all 510(k) review times · Search every FTL clearance
Top FTL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sofradim Production | 36 | 2026-05-21 |
| W. L. Gore & Associates, Inc. | 36 | 2017-05-11 |
| C.R. Bard, Inc. | 25 | 2020-07-17 |
| ETHICON, Inc. | 24 | 2020-08-06 |
| Atrium Medical Corp. | 11 | 2012-04-26 |
116 more applicants have FTL clearances. See the full list in Caduvo.
Most recent FTL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253956 | Sofradim Production | ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) | 2026-05-21 | 162 |
| K253125 | Medtronic - Sofradim Production | Parietene Flat Sheet Mesh | 2025-10-24 | 29 |
| K251955 | Davol Inc., Subsidiary of C. R. Bard, Inc. | Onflex Mesh | 2025-07-24 | 29 |
| K251557 | Davol, Inc. | Bard® Mesh; Bard® Mesh Pre-Shaped | 2025-06-12 | 22 |
| K250869 | Sofradim Production | Parietene Macroporous Mesh (PPM5050 ) | 2025-04-23 | 30 |
Recalls for FTL devices
73 product recalls in 47 recall events; 10 initiated in the last five years and 7 still open. Most recent: 2024-07-03.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 3 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 4 |
| 2023 | 5 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code FTL?
FTL is the FDA product code for mesh, surgical, polymeric. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel.
What device class is FTL?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code FTL?
Across 336 cleared submissions the average was 118 days from receipt to decision (median 89).
Which companies have the most FTL clearances?
Sofradim Production (36); W. L. Gore & Associates, Inc. (36); C.R. Bard, Inc. (25); ETHICON, Inc. (24); Atrium Medical Corp. (11).
Have FTL devices been recalled?
Yes: 73 product recalls across 47 recall events; the most recent began 2024-07-03.
Next steps
- Run an FDA pathway report with predicate devices for product code FTL
- Run a recall and safety report across every FTL manufacturer
- Watch product code FTL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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