FDA product code GAW: Suture, Nonabsorbable, Synthetic, Polypropylene
GAW is the FDA product code for suture, nonabsorbable, synthetic, polypropylene. It is a Class II device, regulated under 21 CFR 878.5010 and reviewed by the General and Plastic Surgery panel. FDA has cleared 85 510(k) submissions under GAW, 5 in the last five years, from 56 different applicants. The average 510(k) review took 125 days (median 84); 118 days on average over the last three years. 2 PMA applications cite this product code. FDA has posted 28 recalls for GAW devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device class | Class II |
| Regulation | 21 CFR 878.5010 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for GAW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 124 |
| 2018 | 3 | 163 |
| 2019 | 1 | 31 |
| 2020 | 2 | 200 |
| 2022 | 2 | 360 |
| 2023 | 1 | 181 |
| 2024 | 1 | 105 |
| 2026 | 1 | 130 |
Compare with all 510(k) review times · Search every GAW clearance
Top GAW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgical Specialties Corp | 5 | 2005-12-06 |
| Axya Medical, Inc. | 5 | 2000-10-06 |
| ETHICON, Inc. | 4 | 2026-03-27 |
| Sutura, Inc. | 4 | 2006-10-19 |
| Aesculap, Inc. | 3 | 2018-03-07 |
51 more applicants have GAW clearances. See the full list in Caduvo.
Most recent GAW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253572 | ETHICON, Inc. | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device | 2026-03-27 | 130 |
| K233355 | Cypris Medical | Cypris eXact Suturing System | 2024-01-12 | 105 |
| K230746 | Shandong Haidike Medical Products Co., Ltd. | Non absorbable Surgical Polypropylene Suture | 2023-09-14 | 181 |
| K221280 | Lydus Medical , Ltd. | Vesseal | 2022-12-09 | 220 |
| K211178 | Msi | DURAMESH Mesh Suture | 2022-09-02 | 500 |
Recalls for GAW devices
28 product recalls in 6 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2026-06-24.
| Year | Recalls |
|---|---|
| 2018 | 19 |
| 2022 | 2 |
| 2024 | 3 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code GAW?
GAW is the FDA product code for suture, nonabsorbable, synthetic, polypropylene. It is a Class II device, regulated under 21 CFR 878.5010 and reviewed by the General and Plastic Surgery panel.
What device class is GAW?
Class II, regulation 21 CFR 878.5010. Typical premarket route: 510(k).
How long does a 510(k) take for product code GAW?
Across 85 cleared submissions the average was 125 days from receipt to decision (median 84).
Which companies have the most GAW clearances?
Surgical Specialties Corp (5); Axya Medical, Inc. (5); ETHICON, Inc. (4); Sutura, Inc. (4); Aesculap, Inc. (3).
Have GAW devices been recalled?
Yes: 28 product recalls across 6 recall events; the most recent began 2026-06-24.
Next steps
- Run an FDA pathway report with predicate devices for product code GAW
- Run a recall and safety report across every GAW manufacturer
- Watch product code GAW 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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