KTG
5 FDA 510(k) clearances · Product code
32 daysmedian time to decision
38 days90th percentile
5clearances measured
FDA profile
- Official device name
- Knife, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Medical specialty
- Ear, Nose, Throat
- Adverse events (MAUDE)
- 1996: 1 · 1997: 2 · 1998: 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 |
|---|---|---|
| ENT KNIFE HANDLES (K822280) | Kelleher Corp. | 1982-08-30 |
| KNIVES, ENT (K822205) | Kelleher Corp. | 1982-08-30 |
| LANCETS FOR EAR SURGERY (K822279) | Kelleher Corp. | 1982-08-25 |
| TONSIL DISSECTORS (K822187) | Kelleher Corp. | 1982-08-24 |
| KNIFE HANDLE (K822203) | Kelleher Corp. | 1982-08-20 |
Track KTG automatically
Every clearance here is in the API, with alerts when new ones post.