KNE
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Set, Anesthesia, Obstetric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5100
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 1 · 1994: 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 |
|---|---|---|
| PUDENDAL/LOCAL ANESTESIA BLOCK TRAY (K880988) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-06-01 |
| EPICATH (K862358) | Hdc Corp. | 1986-07-07 |
Track KNE automatically
Every clearance here is in the API, with alerts when new ones post.