GDG
10 FDA 510(k) clearances · Product code
32 daysmedian time to decision
113 days90th percentile
10clearances measured
FDA profile
- Official device name
- Hook, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2013: 15 · 2014: 21 · 2015: 35 · 2016: 14 · 2018: 11 · 2021: 18
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 |
|---|---|---|
| MODIFIED PGL ABSORBABLE STAPLE* (K900069) | United States Surgical, A Division of Tyco Healthc | 1990-04-16 |
| SKIN HOOKS, VARIOUS TYPES (K891898) | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| RAYLOR(TM) DISSECTING HOOK (K864425) | Cedar Surgical, Inc. | 1986-12-12 |
| BRIMFIELD CANNULATED GRASPING HOOKS (K843136) | Brimfield Scientific Instruments | 1984-09-25 |
| SURGICAL HOOKS, VARIOUS (K841010) | Premier Dental Products Co. | 1984-05-01 |
| SURGICAL RETRACTOR & ELASTIC STAYS, DISP (K812562) | Humboldt Products | 1981-10-02 |
| MIDDLE EAR PICKS, HOOKS CURETTES, (K791120) | Xomed, Inc. | 1979-07-10 |
| NERVE APPROXIMATER (K780289) | Edward Weck, Inc. | 1978-06-14 |
| ABRAMSON TRACHEA HOOK & RETRACTOR (K771190) | Edward Weck, Inc. | 1977-07-11 |
| DERMAHOOK #382-805 (K771187) | Edward Weck, Inc. | 1977-07-11 |
Track GDG automatically
Every clearance here is in the API, with alerts when new ones post.