Product code PNZ— Ear, Nose, Throat
ACCLARENT AERA Eustachian Tube Balloon Dilation System
- Classification name
- Eustachian Tube Balloon Dilation Device
- Device class
- Class 2
- Regulation
- 21 CFR 874.4180
- Advisory panel
- Ear, Nose, Throat
- Total cleared
- 9
- First cleared
- Most recent
FDA classification definition
“The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.”
Market context for product code PNZ
FDA has cleared devices under product code PNZ between 2016 and 2026, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2023
- 2022
- 2021
- 2018
- 2017
- 2016
Top applicants under product code PNZ
Recent clearances under product code PNZ
- K253612 — Acclarent AERA Eustachian Tube Balloon Dilation System
- K230742 — ACCLARENT AERA Eustachian Tube Dilation System
- K223542 — TubaVent Balloon Dilatation System
- K230065 — VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System
- K220027 — Audion ET dilation system
- K210841 — NuVent Eustachian Tube Dilation Balloon
- K171761 — ACCLARENT AERA Eustachian Tube Balloon Dilation System
- K163509 — XprESS ENT Dilation System
- DEN150056 — Acclarent Aera Eustachian Tube Balloon Dilation System
Data sourced from openFDA. This site is unofficial and independent of the FDA.