JYG
7 FDA 510(k) clearances · Product code
35 daysmedian time to decision
95 days90th percentile
7clearances measured
FDA profile
- Official device name
- Curette, Ear
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Medical specialty
- Ear, Nose, Throat
- Adverse events (MAUDE)
- 2000: 1 · 2002: 2 · 2004: 3 · 2005: 2 · 2006: 2 · 2007: 3
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 |
|---|---|---|
| EAR CURETTE (K932609) | Ear Tech, Inc. | 1993-07-21 |
| FLEX-LOOP FLEXIBLE EAR CORETTE (K852039) | Bionix Corp. | 1985-06-11 |
| CURETTE (K841354) | Treace Medical, Inc. | 1984-07-06 |
| EAR CURETTE, VARIOUS (K841001) | Premier Dental Products Co. | 1984-05-29 |
| WAX CURETTE TIP (K823916) | Treace Medical, Inc. | 1983-01-21 |
| ENT CURRETTES (K822273) | Kelleher Corp. | 1982-08-30 |
| OPERATIVE EAR CURRETTES & RELATED ITEM (K822006) | Kelleher Corp. | 1982-08-12 |
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Every clearance here is in the API, with alerts when new ones post.