GAH
7 FDA 510(k) clearances · Product code
86 daysmedian time to decision
297 days90th percentile
7clearances measured
FDA profile
- Official device name
- Stylet, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1993: 1
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 |
|---|---|---|
| VENX REVOLUTION (K110355) | Venx, LLC | 2011-04-22 |
| ARACHNOPHLEBECTOMY NEEDLE (K000932) | Advanced Medical Products, Inc. | 2000-05-17 |
| MARKMAN TEMPLATE SYSTEM (K970306) | Barry Markman, M.D. | 1997-11-20 |
| RAPID FIRE HAIR IMPLANTER CAROUSEL (K972918) | Apex Medical Products, LLC | 1997-10-27 |
| NAVIGATOR (STYLET) 2006 (K972521) | Sil-Med Corp. | 1997-10-01 |
| CALVITRON HAIR TRANSPLANT SYSTEM (K952737) | Medicamat S.A. | 1995-10-03 |
| HAIR TRANSPLANT PUNCH, MULTIPLH (K770970) | Padgett Instruments, Inc. | 1977-10-27 |
Track GAH automatically
Every clearance here is in the API, with alerts when new ones post.