PNZ
9 FDA 510(k) clearances · Product code
147 daysmedian time to decision
284 days90th percentile
9clearances measured
FDA profile
- Official device name
- Eustachian Tube Balloon Dilation Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4180
- Medical specialty
- Ear, Nose, Throat
- FDA definition
- The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Acclarent AERA Eustachian Tube Balloon Dilation System (K253612) | Acclarent, Inc. | 2026-02-19 |
| ACCLARENT AERA Eustachian Tube Dilation System (K230742) | Acclarent, Inc. | 2023-12-13 |
| TubaVent Balloon Dilatation System (K223542) | Spiggle & Theis Medizintechnik GmbH | 2023-08-03 |
| VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System (K230065) | Fiagon GmbH | 2023-05-26 |
| Audion ET dilation system (K220027) | Entellus Medical, Inc. | 2022-04-12 |
| NuVent Eustachian Tube Dilation Balloon (K210841) | Medtronic Xomed, Inc. | 2021-08-16 |
| ACCLARENT AERA Eustachian Tube Balloon Dilation System (K171761) | Acclarent, Inc. | 2018-01-16 |
| XprESS ENT Dilation System (K163509) | Entellus Medical, Inc. | 2017-04-05 |
| Acclarent Aera Eustachian Tube Balloon Dilation System (DEN150056) | Acclarent, Inc. | 2016-09-16 |
Track PNZ automatically
Every clearance here is in the API, with alerts when new ones post.