Panels › Ear, Nose, Throat › Product code PNZ · Class 2
Eustachian Tube Balloon Dilation Device
Regulation 874.4180
1510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PNZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Acclarent, Inc. | 4 | 0 |
| Entellus Medical, Inc. | 2 | 0 |
| Fiagon GmbH | 1 | 0 |
| Medtronic Xomed, Inc. | 1 | 0 |
| Spiggle & Theis Medizintechnik GmbH | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 19, 2026 | K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System Acclarent, Inc. | PNZ |
| Dec 13, 2023 | K230742 | ACCLARENT AERA Eustachian Tube Dilation System Acclarent, Inc. | PNZ |
| Aug 3, 2023 | K223542 | TubaVent Balloon Dilatation System Spiggle & Theis Medizintechnik GmbH, DE | PNZ |
| May 26, 2023 | K230065 | VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure Fiagon GmbH, DE | PNZ |
| Apr 12, 2022 | K220027 | Audion ET dilation system Entellus Medical, Inc. | PNZ |
| Aug 16, 2021 | K210841 | NuVent Eustachian Tube Dilation Balloon Medtronic Xomed, Inc. | PNZ |
| Jan 16, 2018 | K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation System Acclarent, Inc. | PNZ |
| Apr 5, 2017 | K163509 | XprESS ENT Dilation System Entellus Medical, Inc. | PNZ |
| Sep 16, 2016 | DEN150056 | Acclarent Aera Eustachian Tube Balloon Dilation System Acclarent, Inc. | PNZ |
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