KBN
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Gag, Mouth
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Medical specialty
- Ear, Nose, Throat
- Adverse events (MAUDE)
- 1996: 12 · 1997: 3 · 1998: 2 · 2000: 1 · 2003: 2 · 2008: 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 |
|---|---|---|
| OP-CON SURGICAL INSTRUMENT #9 (K834540) | Imm Enterprises , Ltd. | 1984-03-06 |
| MOUTH GAGS (K822183) | Kelleher Corp. | 1982-08-16 |
| MILLARD MOUTH GAG (K780992) | Nestor Engineering Associates, Inc. | 1978-08-17 |
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Every clearance here is in the API, with alerts when new ones post.