EPE
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Brush, Cleaning, Tracheal Tube
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5795
- Medical specialty
- Anesthesiology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1995: 2 · 1996: 1 · 2002: 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 |
|---|---|---|
| UPDATED STERILE ENDOTRACHEAL BRUSHES (K863635) | Biological & Environmental Control Laboratories | 1986-11-03 |
| TRACHEOSTOMY CLEANSING SOLUTION (K862563) | Clinipad Corp. | 1986-07-15 |
Track EPE automatically
Every clearance here is in the API, with alerts when new ones post.