FDA product code · General, Plastic Surgery · Class 2
GAW: Suture, Nonabsorbable, Synthetic, Polypropylene
GAW is FDA's product code for "Suture, Nonabsorbable, Synthetic, Polypropylene": a Class 2 device classified under 21 CFR 878.5010, reviewed by the General, Plastic Surgery panel. FDA flags it as an implant.
510(k) review time for GAW
Across 11 510(k) clearances under GAW decided from 2018-01-01 to 2026-10-06, the median was 130 days from FDA receipt to decision. Half took between 85 and 266 days, and 80% were decided within 311 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 85 |
| Median | 130 |
| 75th percentile | 266 |
| 80th percentile | 311 |
| 90th percentile | 378 |
| Slowest | 500 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
GAW in the public FDA record
| 510(k) clearances, all years | 85 |
|---|---|
| Device recalls | 28 |
| Establishment listings | 227 |
| GUDID device identifiers | 7,895 |
Counts of records, not of devices or events. Adverse event reports for GAW are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite GAW
6 FDA recognized consensus standards cite GAW, 1 of them recognized only in part, among them USP-NF M80200_04_01; USP-NF M99670_02_01; USP-NF M99650_02_01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 6-467 USP-NF M80200_04_01 — Nonabsorbable Surgical Suture
- 6-468 USP-NF M99670_02_01 — <881> Tensile Strength
- 6-469 USP-NF M99650_02_01 — <861> Sutures - Diameter
- 6-470 USP-NF M99660_03_01 — <871> Sutures - Needle Attachment
- 8-179 ASTM F754-08 (Reapproved 2015) (partial recognition) — Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet Tube and Rod Shapes Fabricated from Granular Molding Powders
- 8-628 ASTM F754-24 — Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet Tube and Rod Shapes Fabricated from Granular Molding Powders
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.