FDA Product Code
FDA Product Code PNZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.4180
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2026-02-19 | Traditional | PDF ↗ |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation System | Acclarent, Inc. | 2023-12-13 | Traditional | PDF ↗ |
| K223542 | TubaVent Balloon Dilatation System | Spiggle & Theis Medizintechnik GmbH | 2023-08-03 | Traditional | PDF ↗ |
| K230065 | VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System | Fiagon GmbH | 2023-05-26 | Traditional | PDF ↗ |
| K220027 | Audion ET dilation system | Entellus Medical, Inc. | 2022-04-12 | Traditional | PDF ↗ |
| K210841 | NuVent Eustachian Tube Dilation Balloon | Medtronic Xomed, Inc. | 2021-08-16 | Traditional | PDF ↗ |
| K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2018-01-16 | Traditional | PDF ↗ |
| K163509 | XprESS ENT Dilation System | Entellus Medical, Inc. | 2017-04-05 | Traditional | PDF ↗ |
| DEN150056 | Acclarent Aera Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2016-09-16 | Direct | — |
Product code PNZ · Class II · Ear, Nose, Throat. Data: openFDA.