ACCLARENT AERA Eustachian Tube Balloon Dilation System
FDA 510(k) K171761 · Acclarent, Inc.
510(k) numberK171761
Submission
- Device name
- ACCLARENT AERA Eustachian Tube Balloon Dilation System
- Applicant
- Acclarent, Inc.
Irvin, CA, US - Received
- June 14, 2017
- Decision date
- January 16, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PNZ – Eustachian Tube Balloon Dilation Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4180
- Specialty
- Ear, Nose, Throat
The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
Other 510(k)s with product code PNZ
| 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 |
| K163509 | XprESS ENT Dilation SystemPNZ · Traditional | Entellus Medical, Inc. | 04/05/2017SE |
More from Entellus Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation SystemPNZ · Traditional | 02/19/2026SE |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation SystemPNZ · Traditional | 12/13/2023SE |
| K231862 | TruDi® Navigation System V3 (FG-2000-00)PGW · Special | 07/21/2023SE |
| K221037 | TruDi Shaver BladePGW · Traditional | 07/20/2022SE |
| K201115 | Next Generation Balloon Dilation SystemLRC · Traditional | 08/27/2020SE |
| K201174 | TruDi CurettePGW · Traditional | 08/12/2020SE |
| K193453 | TruDi ProbePGW · Traditional | 03/23/2020SE |
| K190532 | TruDi NAV WirePGW · Traditional | 05/03/2019SE |
| K190525 | RELIEVA ULTIRRA Sinus Balloon CatheterLRC · Traditional | 05/03/2019SE |
| K183090 | Relieva Tract Balloon Dilation SystemQGK · Traditional | 04/19/2019SE |
Questions and answers
When was ACCLARENT AERA Eustachian Tube Balloon Dilation System cleared by the FDA?
ACCLARENT AERA Eustachian Tube Balloon Dilation System (K171761) received a 510(k) decision of Substantially Equivalent on January 16, 2018, 216 days after the submission was received.
What is the product code of K171761?
The FDA product code is PNZ – Eustachian Tube Balloon Dilation Device, a Class II (moderate risk) device regulated under 21 CFR 874.4180.