GAK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Suture, Absorbable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4830
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- Adverse events (MAUDE)
- 2020: 22 · 2021: 13 · 2022: 20 · 2023: 33 · 2024: 29 · 2025: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DEXON DISSECTING SPONGE (K914365) | Davis & Geck, Inc. | 1991-10-23 |
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Every clearance here is in the API, with alerts when new ones post.