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PNZ — Eustachian Tube Balloon Dilation Device Class II

FDA Device Classification

Classification Details

Product Code
PNZ
Device Class
Class II
Regulation Number
874.4180
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Definition

The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253612acclarentAcclarent AERA Eustachian Tube Balloon Dilation SystemFebruary 19, 2026
K230742acclarentACCLARENT AERA Eustachian Tube Dilation SystemDecember 13, 2023
K223542spiggle and theis medizintechnikTubaVent Balloon Dilatation SystemAugust 3, 2023
K230065fiagonVenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSurMay 26, 2023
K220027entellus medicalAudion ET dilation systemApril 12, 2022
K210841medtronic xomedNuVent Eustachian Tube Dilation BalloonAugust 16, 2021
K171761acclarentACCLARENT AERA Eustachian Tube Balloon Dilation SystemJanuary 16, 2018
K163509entellus medicalXprESS ENT Dilation SystemApril 5, 2017
DEN150056acclarentAcclarent Aera Eustachian Tube Balloon Dilation SystemSeptember 16, 2016