GCE
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Adaptor, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1999: 1 · 2000: 2 · 2004: 2 · 2008: 12
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 |
|---|---|---|
| KLEIN CONNECTOR(TM) (K901716) | Jeff Klein Surgical, Inc. | 1990-05-11 |
| KLEIN CORK(TM) (K901715) | Jeff Klein Surgical, Inc. | 1990-05-11 |
| MEDIFLEX INJECTION CAP (K855039) | Mediflex Intl. | 1986-01-24 |
| BETA-CAP II ADAPTER (K801680) | Quinton, Inc. | 1980-08-04 |
Track GCE automatically
Every clearance here is in the API, with alerts when new ones post.