FDA product code FTM: Mesh, Surgical
FTM is the FDA product code for mesh, surgical. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 164 510(k) submissions under FTM, 7 in the last five years, from 73 different applicants. The average 510(k) review took 111 days (median 86); 67 days on average over the last three years. FDA has posted 76 recalls for FTM devices, 29 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical |
| 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 FTM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 127 |
| 2018 | 2 | 177 |
| 2019 | 6 | 130 |
| 2020 | 4 | 126 |
| 2021 | 4 | 95 |
| 2023 | 2 | 320 |
| 2024 | 3 | 79 |
| 2025 | 1 | 95 |
| 2026 | 1 | 28 |
Compare with all 510(k) review times · Search every FTM clearance
Top FTM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Biotech, Inc. | 14 | 2014-07-23 |
| Tei Biosciences, Inc. | 7 | 2017-02-16 |
| Bio-Vascular, Inc. | 7 | 2000-02-22 |
| Cook Biotech Incorporated | 6 | 2020-07-13 |
| Acell, Inc. | 6 | 2019-02-07 |
68 more applicants have FTM clearances. See the full list in Caduvo.
Most recent FTM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262406 | Boston Scientific | EluPro Antibiotic-Eluting BioEnvelope | 2026-08-12 | 28 |
| K250598 | Aroa Biosurgery , Ltd. | Endoform Reconstructive Template - PLGA | 2025-06-03 | 95 |
| K243595 | TELA Bio, Inc. | OviTex PRS (Long-Term Resorbable) | 2024-12-19 | 29 |
| K233991 | Elutia, Inc. | CanGaroo RM Antibacterial Envelope | 2024-06-14 | 179 |
| K241126 | TELA Bio, Inc. | OviTex PRS | 2024-05-22 | 29 |
Recalls for FTM devices
76 product recalls in 21 recall events; 29 initiated in the last five years and 29 still open. Most recent: 2024-08-07.
| Year | Recalls |
|---|---|
| 2018 | 21 |
| 2019 | 4 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 12 |
| 2024 | 16 |
Frequently asked questions
What is FDA product code FTM?
FTM is the FDA product code for mesh, surgical. 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 FTM?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code FTM?
Across 164 cleared submissions the average was 111 days from receipt to decision (median 86).
Which companies have the most FTM clearances?
Cook Biotech, Inc. (14); Tei Biosciences, Inc. (7); Bio-Vascular, Inc. (7); Cook Biotech Incorporated (6); Acell, Inc. (6).
Have FTM devices been recalled?
Yes: 76 product recalls across 21 recall events; the most recent began 2024-08-07.
Next steps
- Run an FDA pathway report with predicate devices for product code FTM
- Run a recall and safety report across every FTM manufacturer
- Watch product code FTM 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times