GAB
8 FDA 510(k) clearances · Product code
85 daysmedian time to decision
208 days90th percentile
8clearances measured
FDA profile
- Official device name
- Needle, Suturing, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2021: 17 · 2022: 17 · 2023: 32 · 2024: 26 · 2025: 38 · 2026: 15
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 |
|---|---|---|
| DIGICAP (K012199) | Humana USA, Inc. | 2001-12-19 |
| AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) (K980988) | Axya Medical, Inc. | 1998-05-11 |
| ENDO-JUDGE (K932591) | Synergistic Medical Technologies, Inc. | 1993-12-22 |
| CONTRAST BACKGROUND MATERIAL (K895681) | Applied Medical Technologies | 1989-10-24 |
| COATED SUTURE NEEDLE (K863595) | Sharpoint, Inc. | 1986-10-24 |
| ANCHOR BRAND SURGICAL NEEDLES (K831648) | Anchor Products Co. | 1983-08-16 |
| RADIATION STERILIZATION FOR NEEDLE CNTR (K812444) | Devon Industries, Inc. | 1981-12-14 |
| SCANLAN STERNUM NEEDLE-SUTURE (K801976) | Scanlan Intl., Inc. | 1980-09-26 |
Track GAB automatically
Every clearance here is in the API, with alerts when new ones post.