KCD
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Bougie, Esophageal, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Medical specialty
- Ear, Nose, Throat
- Adverse events (MAUDE)
- 1992: 1 · 1995: 1 · 1998: 1 · 1999: 1 · 2000: 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 |
|---|---|---|
| VOLUMATIC (K844169) | Glaxo, Inc. | 1984-11-09 |
| ESOPHAGEAL BOUGIES (K822258) | Kelleher Corp. | 1982-08-25 |
| JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE (K800623) | Pilling Co. | 1980-04-24 |
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Every clearance here is in the API, with alerts when new ones post.