FDA product code GAM: Suture, Absorbable, Synthetic, Polyglycolic Acid
GAM is the FDA product code for suture, absorbable, synthetic, polyglycolic acid. It is a Class II device, regulated under 21 CFR 878.4493 and reviewed by the General and Plastic Surgery panel. FDA has cleared 149 510(k) submissions under GAM, 11 in the last five years, from 59 different applicants. The average 510(k) review took 116 days (median 86); 198 days on average over the last three years. 3 PMA applications cite this product code. FDA has posted 130 recalls for GAM devices, 13 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class II |
| Regulation | 21 CFR 878.4493 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for GAM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 8 | 136 |
| 2018 | 5 | 101 |
| 2019 | 4 | 122 |
| 2020 | 3 | 120 |
| 2021 | 2 | 91 |
| 2022 | 2 | 244 |
| 2023 | 1 | 264 |
| 2024 | 2 | 358 |
| 2025 | 3 | 58 |
| 2026 | 3 | 177 |
Compare with all 510(k) review times · Search every GAM clearance
Top GAM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ETHICON, Inc. | 26 | 2026-06-25 |
| United States Surgical, A Division of Tyco Healthc | 12 | 2003-11-17 |
| Aesculap, Inc. | 7 | 2017-10-23 |
| Surgical Specialties Corp | 7 | 2014-07-18 |
| Foosin Medical Supplies Inc., Ltd. | 5 | 2019-01-28 |
54 more applicants have GAM clearances. See the full list in Caduvo.
Most recent GAM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253394 | ETHICON, Inc. | Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture | 2026-06-25 | 268 |
| K253530 | Medtronic | Trexon Monofilament Synthetic Absorbable Suture | 2026-05-28 | 196 |
| K253852 | ETHICON, Inc. | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | 2026-02-06 | 66 |
| K252743 | ETHICON, Inc. | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | 2025-12-22 | 116 |
| K253620 | Gordian Surgical, Ltd. | TroClose 1200 | 2025-12-16 | 28 |
Recalls for GAM devices
130 product recalls in 35 recall events; 13 initiated in the last five years and 15 still open. Most recent: 2026-06-24.
| Year | Recalls |
|---|---|
| 2017 | 10 |
| 2018 | 1 |
| 2019 | 29 |
| 2020 | 44 |
| 2022 | 4 |
| 2024 | 7 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code GAM?
GAM is the FDA product code for suture, absorbable, synthetic, polyglycolic acid. It is a Class II device, regulated under 21 CFR 878.4493 and reviewed by the General and Plastic Surgery panel.
What device class is GAM?
Class II, regulation 21 CFR 878.4493. Typical premarket route: 510(k).
How long does a 510(k) take for product code GAM?
Across 149 cleared submissions the average was 116 days from receipt to decision (median 86).
Which companies have the most GAM clearances?
ETHICON, Inc. (26); United States Surgical, A Division of Tyco Healthc (12); Aesculap, Inc. (7); Surgical Specialties Corp (7); Foosin Medical Supplies Inc., Ltd. (5).
Have GAM devices been recalled?
Yes: 130 product recalls across 35 recall events; the most recent began 2026-06-24.
Next steps
- Run an FDA pathway report with predicate devices for product code GAM
- Run a recall and safety report across every GAM manufacturer
- Watch product code GAM 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