KCF
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dilator, Esophageal, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Medical specialty
- Ear, Nose, Throat
- Adverse events (MAUDE)
- 1994: 2 · 1995: 2 · 1998: 1
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 |
|---|---|---|
| MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE (K962688) | Boston Medical Products, Inc. | 1996-07-25 |
| PHARYNGEAL SALIVARY BYPASS TUBE (K923355) | Boston Medical Products, Inc. | 1992-10-06 |
| MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE (K812305) | Boston Medical Products, Inc. | 1981-09-08 |
Track KCF automatically
Every clearance here is in the API, with alerts when new ones post.