QGK

Balloon, Nasal Airway

Product code

QGK

Device name

Balloon, Nasal Airway

Device class

Class 1

21 CFR

21 CFR 874.4420

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

The nasal airway balloon is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction.

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