Product code PNZ
- Device name
- Eustachian Tube Balloon Dilation Device
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.4180
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2026-02-19 |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation System | Acclarent, Inc. | 2023-12-13 |
| K223542 | TubaVent Balloon Dilatation System | Spiggle & Theis Medizintechnik GmbH | 2023-08-03 |
| 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 |
| K220027 | Audion ET dilation system | Entellus Medical, Inc. | 2022-04-12 |
| K210841 | NuVent Eustachian Tube Dilation Balloon | Medtronic Xomed, Inc. | 2021-08-16 |
| K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2018-01-16 |
| K163509 | XprESS ENT Dilation System | Entellus Medical, Inc. | 2017-04-05 |
| DEN150056 | Acclarent Aera Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2016-09-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04260759931680 | VenSure 4D Balloon Dilation System | Fiagon GmbH | 2025-09-18 |
| 04250676745088 | TubaVent® balloon dilatation system | Spiggle & Theis Medizintechnik GmbH | 2025-02-27 |
| 04250676743527 | TubaInsert® - Type 45° | Spiggle & Theis Medizintechnik GmbH | 2023-09-07 |
| 04250676743510 | TubaVent® short wide | Spiggle & Theis Medizintechnik GmbH | 2023-09-07 |
| 04250676743503 | TubaVent® short | Spiggle & Theis Medizintechnik GmbH | 2023-09-07 |
| 04250676743473 | Inflation device | Spiggle & Theis Medizintechnik GmbH | 2023-09-07 |
| 04260759931260 | VenSure Nav Balloon Dilation System | Fiagon GmbH | 2022-11-10 |
| 04260759931246 | VenSure Balloon Dilation System | Fiagon GmbH | 2022-11-10 |
| 04260759931253 | VenSure Light Balloon Dilation System | Fiagon GmbH | 2022-10-14 |
| 00850002250428 | Audion | STRYKER CORPORATION | 2022-06-03 |
| 00763000416034 | NuVent | MEDTRONIC XOMED, INC. | 2021-10-04 |
| 10705031465565 | ACCLARENT PIVOT | ACCLARENT, INC. | 2020-10-01 |
| 20705031465616 | ACCLARENT PIVOT | ACCLARENT, INC. | 2020-10-01 |
| 20705031465579 | ACCLARENT PIVOT | ACCLARENT, INC. | 2020-10-01 |
| 20705031465609 | ACCLARENT PIVOT | ACCLARENT, INC. | 2020-10-01 |
| 20705031465586 | ACCLARENT PIVOT | ACCLARENT, INC. | 2020-10-01 |
| 10705031465596 | ACCLARENT PIVOT | ACCLARENT, INC. | 2020-10-01 |
| 10705031465572 | ACCLARENT PIVOT | ACCLARENT, INC. | 2020-10-01 |
| 00857326005116 | XprESS Ultra | STRYKER CORPORATION | 2017-11-27 |
| 00857326005130 | XprESS Ultra | STRYKER CORPORATION | 2017-11-27 |
| 00857326005147 | XprESS Ultra | STRYKER CORPORATION | 2017-11-27 |
| 00857326005079 | XprESS Pro | STRYKER CORPORATION | 2017-11-27 |
| 00857326005062 | XprESS Pro | STRYKER CORPORATION | 2017-11-27 |
| 00857326005055 | XprESS Pro | STRYKER CORPORATION | 2017-11-27 |
| 00857326005048 | XprESS LoProfile | STRYKER CORPORATION | 2017-11-27 |
| 00857326005031 | XprESS LoProfile | STRYKER CORPORATION | 2017-11-27 |
| 00857326005024 | XprESS LoProfile | STRYKER CORPORATION | 2017-11-27 |
| 00857326005017 | XprESS LoProfile | STRYKER CORPORATION | 2017-11-27 |
| 00857326005000 | XprESS LoProfile | STRYKER CORPORATION | 2017-11-27 |
| 10705031230880 | ACCLARENT AERA | ACCLARENT, INC. | 2016-11-17 |