QGK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Balloon, Nasal Airway
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Medical specialty
- Ear, Nose, Throat
- FDA definition
- The nasal airway balloon is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Relieva Tract Balloon Dilation System (K183090) | Acclarent, Inc. | 2019-04-19 |
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