FDA product code GAT: Suture, Nonabsorbable, Synthetic, Polyethylene
GAT is the FDA product code for suture, nonabsorbable, synthetic, polyethylene. It is a Class II device, regulated under 21 CFR 878.5000 and reviewed by the General and Plastic Surgery panel. FDA has cleared 176 510(k) submissions under GAT, 26 in the last five years, from 88 different applicants. The average 510(k) review took 129 days (median 90); 116 days on average over the last three years. 3 PMA applications cite this product code. FDA has posted 23 recalls for GAT devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class II |
| Regulation | 21 CFR 878.5000 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for GAT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 6 | 71 |
| 2018 | 6 | 122 |
| 2019 | 4 | 114 |
| 2020 | 5 | 234 |
| 2021 | 4 | 96 |
| 2022 | 5 | 120 |
| 2023 | 8 | 262 |
| 2024 | 3 | 161 |
| 2025 | 5 | 77 |
| 2026 | 5 | 110 |
Compare with all 510(k) review times · Search every GAT clearance
Top GAT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthrex, Inc. | 19 | 2022-10-27 |
| Smith & Nephew, Inc. | 11 | 2021-02-01 |
| Riverpoint Medical | 6 | 2025-10-16 |
| Threadstone, LLC | 5 | 2026-03-23 |
| Medos International SARL | 5 | 2022-04-26 |
83 more applicants have GAT clearances. See the full list in Caduvo.
Most recent GAT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253910 | GM Dos Reis Industria e Comercio Ltda. | Stitch - Suture Wires and Tapes | 2026-08-22 | 257 |
| K261021 | Winter Innovations, Inc. | EasyWhip Family | 2026-07-01 | 96 |
| K260775 | Teleflex Medical, LLC | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape | 2026-05-06 | 57 |
| K254275 | Threadstone, LLC | HyperSuture All Green Extension Line | 2026-03-23 | 83 |
| K254188 | GM Dos Reis Industria e Comercio Ltda. | Meniscus Versaflex | 2026-02-19 | 58 |
Recalls for GAT devices
23 product recalls in 11 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2022-12-02.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2022 | 4 |
Frequently asked questions
What is FDA product code GAT?
GAT is the FDA product code for suture, nonabsorbable, synthetic, polyethylene. It is a Class II device, regulated under 21 CFR 878.5000 and reviewed by the General and Plastic Surgery panel.
What device class is GAT?
Class II, regulation 21 CFR 878.5000. Typical premarket route: 510(k).
How long does a 510(k) take for product code GAT?
Across 176 cleared submissions the average was 129 days from receipt to decision (median 90).
Which companies have the most GAT clearances?
Arthrex, Inc. (19); Smith & Nephew, Inc. (11); Riverpoint Medical (6); Threadstone, LLC (5); Medos International SARL (5).
Have GAT devices been recalled?
Yes: 23 product recalls across 11 recall events; the most recent began 2022-12-02.
Next steps
- Run an FDA pathway report with predicate devices for product code GAT
- Run a recall and safety report across every GAT manufacturer
- Watch product code GAT 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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