FDA product code GAR: Suture, Nonabsorbable, Synthetic, Polyamide
GAR is the FDA product code for suture, nonabsorbable, synthetic, polyamide. It is a Class II device, regulated under 21 CFR 878.5020 and reviewed by the General and Plastic Surgery panel. FDA has cleared 57 510(k) submissions under GAR, 3 in the last five years, from 43 different applicants. The average 510(k) review took 171 days (median 131); 29 days on average over the last three years. 4 PMA applications cite this product code. FDA has posted 14 recalls for GAR devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class II |
| Regulation | 21 CFR 878.5020 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for GAR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 262 |
| 2020 | 1 | 268 |
| 2021 | 1 | 127 |
| 2022 | 1 | 202 |
| 2023 | 1 | 457 |
| 2026 | 1 | 29 |
Compare with all 510(k) review times · Search every GAR clearance
Top GAR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| S. Jackson, Inc. | 4 | 1993-12-17 |
| Aesculap, Inc. | 3 | 2016-02-17 |
| Sutures , Ltd. | 3 | 1994-12-05 |
| Look, Inc. | 3 | 1993-12-17 |
| United States Surgical, A Division of Tyco Healthc | 3 | 1991-01-29 |
38 more applicants have GAR clearances. See the full list in Caduvo.
Most recent GAR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261484 | Tas Medical, Inc. | Tissue Approximation System | 2026-06-03 | 29 |
| K220980 | Tas Medical, Inc. | Tissue Approximation System (TAS) | 2023-07-05 | 457 |
| K212888 | Antarma, LLC Dba Golnit Sutures | Golnit Nylon Monofilament Suture | 2022-03-31 | 202 |
| K212603 | Shandong Haidike Medical Product Co., Ltd. | Non Absorbable Surgical Nylon Suture | 2021-12-22 | 127 |
| K192420 | Kono Seisakusho Co., Ltd. | Crownjun Nylon Suture | 2020-05-29 | 268 |
Recalls for GAR devices
14 product recalls in 10 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2026-06-24.
| Year | Recalls |
|---|---|
| 2022 | 4 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code GAR?
GAR is the FDA product code for suture, nonabsorbable, synthetic, polyamide. It is a Class II device, regulated under 21 CFR 878.5020 and reviewed by the General and Plastic Surgery panel.
What device class is GAR?
Class II, regulation 21 CFR 878.5020. Typical premarket route: 510(k).
How long does a 510(k) take for product code GAR?
Across 57 cleared submissions the average was 171 days from receipt to decision (median 131).
Which companies have the most GAR clearances?
S. Jackson, Inc. (4); Aesculap, Inc. (3); Sutures , Ltd. (3); Look, Inc. (3); United States Surgical, A Division of Tyco Healthc (3).
Have GAR devices been recalled?
Yes: 14 product recalls across 10 recall events; the most recent began 2026-06-24.
Next steps
- Run an FDA pathway report with predicate devices for product code GAR
- Run a recall and safety report across every GAR manufacturer
- Watch product code GAR 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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