510(k) K253612
- Device
- Acclarent AERA Eustachian Tube Balloon Dilation System
- Applicant
- Acclarent, Inc.
- 510(k) number
- K253612
- Product code
- PNZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-19
- Date received
- 2025-11-18
- Regulation
- 874.4180
- Classification name
- Eustachian Tube Balloon Dilation Device
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kweku Biney
- Address
- 31 Technology Dr., Suite 200 Irvine CA US 92618 92618
FDA Registration Numbers#
- 3002858762
- 3016842760
- 1646831
- 3010313588
- 1045254
- 1811755
- 3007225047
- 3005172759
- 3015967359
- 3003678543
- 3005423519
- 3009018440
- 3008087383
- 3003418325
- 3010273872
- 3018094310
- 2183744
Source Documents#
Other 510(k) Records For Product Code PNZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |