GEG
12 FDA 510(k) clearances · Product code
19 daysmedian time to decision
35 days90th percentile
12clearances measured
FDA profile
- Official device name
- Elevator, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1996: 2 · 1997: 5 · 2000: 1 · 2002: 3 · 2003: 2 · 2004: 3
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 |
|---|---|---|
| ELEVATORS, VARIOUS TYPES (K891899) | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE (K891894) | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| SEPTUM ELEVATOR (K890365) | Kinetic Medical Products | 1989-02-03 |
| SURGICAL ELEVATOR (K890253) | Kinetic Medical Products | 1989-01-27 |
| LIGATURE NEEDLES (K890230) | Kinetic Medical Products | 1989-01-27 |
| 1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS (K872491) | Micro-Aire Surgical Instruments, Inc. | 1987-07-16 |
| ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS (K870781) | Buckman Co., Inc. | 1987-03-09 |
| ELEVATOR, COBB SPINAL (K870591) | Military Engineering, Inc. | 1987-02-26 |
| FEMUR WRENCH (K870126) | Orthopedic Systems, Inc. | 1987-02-03 |
| RAYLOR(TM) PERIOSTEAL ELEVATORS (K864421) | Cedar Surgical, Inc. | 1986-11-26 |
| H.R. JAKOBI SURG. INSTRUMENTS 40/41 (K834176) | Imm Enterprises , Ltd. | 1984-01-27 |
| HARRINGTON SPINAL ELEVATOR (K781449) | Orthopedic Equipment Co., Inc. | 1978-09-27 |
Track GEG automatically
Every clearance here is in the API, with alerts when new ones post.