NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER
FDA 510(k) clearance K140542 · decided 2014-06-27
Clearance details
- K-number
- K140542
- Device name
- NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER
- Applicant
- Rhinosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-03-04
- Decision date
- 2014-06-27
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- KMA
- Device class
- 1
- Regulation number
- 874.5550
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Brooklyn Heights, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RINOFLOW MICRONIZED E.N.T. WASH SYSTEM (K973875) | Respironics, Inc. | 1998-01-26 |
| RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM (K963550) | Respironics, Inc. | 1996-11-01 |
| MICROFLOW IRRIGATION SYSTEM (K950078) | Jedmed Instrument Co. | 1995-06-21 |
| POWDER BLOWERS (K822351) | Kelleher Corp. | 1982-09-14 |
Recalls involving this device
No recalls on record reference this clearance.