PNZ · Class II · 21 CFR 874.4180

FDA Product Code PNZ: Eustachian Tube Balloon Dilation Device

Chronic Eustachian tube dysfunction causes ear pressure, hearing loss, and recurrent otitis media. FDA product code PNZ covers Eustachian tube balloon dilation devices.

These devices are inserted through the nose and nasopharynx to dilate the cartilaginous Eustachian tube using an inflatable balloon, improving tube function and ventilation of the middle ear in patients with chronic Eustachian tube dysfunction who have failed medical therapy.

PNZ devices are Class II medical devices, regulated under 21 CFR 874.4180 and reviewed by the FDA Ear, Nose & Throat panel.

Leading manufacturers include Acclarent, Inc., Medtronic Xomed, Inc. and Entellus Medical, Inc..

4
Total
4
Cleared
152d
Avg days
2021
Since

List of Eustachian Tube Balloon Dilation Device devices cleared through 510(k)

4 devices
1–4 of 4
Cleared Feb 19, 2026
Acclarent AERA Eustachian Tube Balloon Dilation System
K253612
Acclarent, Inc.
Ear, Nose, Throat · 93d
Cleared Dec 13, 2023
ACCLARENT AERA Eustachian Tube Dilation System
K230742
Acclarent, Inc.
Ear, Nose, Throat · 271d
Cleared Apr 12, 2022
Audion ET dilation system
K220027
Entellus Medical, Inc.
Ear, Nose, Throat · 97d
Cleared Aug 16, 2021
NuVent Eustachian Tube Dilation Balloon
K210841
Medtronic Xomed, Inc.
Ear, Nose, Throat · 147d

How to use this database

This page lists all FDA 510(k) submissions for Eustachian Tube Balloon Dilation Device devices (product code PNZ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Ear, Nose, Throat FDA review panel. Browse all Ear, Nose, Throat devices →