Acclarent Aera Eustachian Tube Balloon Dilation System
FDA 510(k) clearance DEN150056 · decided 2016-09-16
Clearance details
- K-number
- DEN150056
- Device name
- Acclarent Aera Eustachian Tube Balloon Dilation System
- Applicant
- Acclarent, Inc.
- Decision
- Unknown
- Date received
- 2015-12-07
- Decision date
- 2016-09-16
- Days to decision
- 284 days
- Clearance type
- Direct
- Product code
- PNZ
- Device class
- 2
- Regulation number
- 874.4180
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Rmenlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
Recalls involving this device
No recalls on record reference this clearance.