PNZ

Eustachian Tube Balloon Dilation Device

Product code

PNZ

Device name

Eustachian Tube Balloon Dilation Device

Device class

Class 2

21 CFR

21 CFR 874.4180

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

9 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-02-19.

2 summaries are archived here for direct download.