Panels › Ear, Nose, Throat › Product code KAR · Class 1
Irrigator, Sinus
Regulation 874.4420
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KAR
| Company | 510(k)s | Recalls |
|---|---|---|
| Gm Engineering, Inc. | 1 | 0 |
| Hedgepath, LLC | 1 | 0 |
| Jedmed Instrument Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 20, 2013 | K131177 | SINUFLUSH LAVAGE SYSTEM Hedgepath, LLC | KAR |
| Aug 30, 1993 | K931398 | GM SWIVEL VIDEO (TM) IRRIGATOR Gm Engineering, Inc. | KAR |
| Apr 23, 1986 | K861298 | FISCH DRILL IRRIGATOR Jedmed Instrument Co. | KAR |
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