Irrigator, Powered Nasal
FDA product code KMA · Class I (low risk) · 21 CFR 874.5550 · Ear, Nose, Throat
5510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140542 | Navage Nasal Irrigator, Navage Nose CleanerKMA · Traditional | Rhinosystems, Inc. | 06/27/2014SE |
| K973875 | Rinoflow Micronized E.N.T. Wash SystemKMA · Traditional | Respironics, Inc. | 01/26/1998SE |
| K963550 | Rinoflow Micronized E.N..T. Wash SytstemKMA · Traditional | Respironics, Inc. | 11/01/1996SE |
| K950078 | Microflow Irrigation SystemKMA · Traditional | Jedmed Instrument Co. | 06/21/1995SE |
| K822351 | Powder BlowersKMA · Traditional | Kelleher Corp. | 09/14/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1674-2012 | Water Pik Sinusense battery operated device including a blue semi-transparent water…Customer complaints related to cross contamination of sinus rinse solution between the battery compartment… | Water Pik, Inc. | 04/03/2012Terminated |