KAK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Probe, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Medical specialty
- Ear, Nose, Throat
- Adverse events (MAUDE)
- 1994: 1 · 1998: 1 · 1999: 1 · 2000: 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 |
|---|---|---|
| ROSEN'S STAPES NEEDLE EXPLORER (K822277) | Kelleher Corp. | 1982-08-25 |
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Every clearance here is in the API, with alerts when new ones post.