KAR
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Irrigator, Sinus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Medical specialty
- Ear, Nose, Throat
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SINUFLUSH LAVAGE SYSTEM (K131177) | Hedgepath, LLC | 2013-09-20 |
| GM SWIVEL VIDEO (TM) IRRIGATOR (K931398) | Gm Engineering, Inc. | 1993-08-30 |
| FISCH DRILL IRRIGATOR (K861298) | Jedmed Instrument Co. | 1986-04-23 |
Track KAR automatically
Every clearance here is in the API, with alerts when new ones post.