FDA product code · General, Plastic Surgery · Class 2
GAM: Suture, Absorbable, Synthetic, Polyglycolic Acid
GAM is FDA's product code for "Suture, Absorbable, Synthetic, Polyglycolic Acid": a Class 2 device classified under 21 CFR 878.4493, reviewed by the General, Plastic Surgery panel. FDA flags it as an implant.
510(k) review time for GAM
Across 25 510(k) clearances under GAM decided from 2018-01-01 to 2026-10-06, the median was 123 days from FDA receipt to decision. Half took between 90 and 196 days, and 80% were decided within 229 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 90 |
| Median | 123 |
| 75th percentile | 196 |
| 80th percentile | 229 |
| 90th percentile | 309 |
| Slowest | 378 |
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.
GAM in the public FDA record
| 510(k) clearances, all years | 149 |
|---|---|
| Device recalls | 130 |
| Establishment listings | 443 |
| GUDID device identifiers | 18,629 |
Counts of records, not of devices or events. Adverse event reports for GAM 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 GAM
9 FDA recognized consensus standards cite GAM, 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
- 6-473 USP-NF M80190_04_01 — Absorbable Surgical Suture
- 8-589 ASTM F1925-22 — Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
- 8-633 ASTM F2902-24 — Standard Guide for Assessment of Absorbable Polymeric Implants
- 8-638 ASTM F2313-24 — Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
- 8-645 ASTM F1925-24 — Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.