Navage Nasal Irrigator, Navage Nose Cleaner
FDA 510(k) K140542 · Rhinosystems, Inc.
510(k) numberK140542
Submission
- Device name
- Navage Nasal Irrigator, Navage Nose Cleaner
- Applicant
- Rhinosystems, Inc.
Brooklyn Heights, OH, US - Received
- March 4, 2014
- Decision date
- June 27, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KMA – Irrigator, Powered Nasal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5550
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KMA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
Questions and answers
When was Navage Nasal Irrigator, Navage Nose Cleaner cleared by the FDA?
Navage Nasal Irrigator, Navage Nose Cleaner (K140542) received a 510(k) decision of Substantially Equivalent on June 27, 2014, 115 days after the submission was received.
What is the product code of K140542?
The FDA product code is KMA – Irrigator, Powered Nasal, a Class I (low risk) device regulated under 21 CFR 874.5550.