GEJ
5 FDA 510(k) clearances · Product code
50 daysmedian time to decision
101 days90th percentile
5clearances measured
FDA profile
- Official device name
- Carrier, Ligature
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1995: 1 · 2002: 2
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 |
|---|---|---|
| Cypris eXact Suture Placement Device (K240185) | Cypris Medical | 2024-05-03 |
| GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM (K900958) | Solos Endoscopy, Inc. | 1990-04-18 |
| GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATED (K900959) | Solos Endoscopy, Inc. | 1990-04-18 |
| STAMEY NEEDLE (K884553) | Cook Ob/Gyn | 1988-11-14 |
| LIGATURE CARRIER/PACKER, HYDROXYLAPATITE (K874342) | Cox-Uphuff Intl. | 1987-11-13 |
Track GEJ automatically
Every clearance here is in the API, with alerts when new ones post.