Eustachian Tube Balloon Dilation Device
FDA product code PNZ · Class II (moderate risk) · 21 CFR 874.4180 · Ear, Nose, Throat
The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
8510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation SystemPNZ · Traditional | Acclarent, Inc. | 02/19/2026SE |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation SystemPNZ · Traditional | Acclarent, Inc. | 12/13/2023SE |
| K223542 | TubaVent Balloon Dilatation SystemPNZ · Traditional | Spiggle & Theis Medizintechnik GmbH | 08/03/2023SE |
| K230065 | VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav…PNZ · Traditional | Fiagon GmbH | 05/26/2023SE |
| K220027 | Audion ET dilation systemPNZ · Traditional | Entellus Medical, Inc. | 04/12/2022SE |
| K210841 | NuVent Eustachian Tube Dilation BalloonPNZ · Traditional | Medtronic Xomed, Inc. | 08/16/2021SE |
| K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation SystemPNZ · Traditional | Acclarent, Inc. | 01/16/2018SE |
| K163509 | XprESS ENT Dilation SystemPNZ · Traditional | Entellus Medical, Inc. | 04/05/2017SE |