QGK — Balloon, Nasal Airway Class I

FDA Device Classification

Classification Details

Product Code
QGK
Device Class
Class I
Regulation Number
874.4420
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K183090acclarentRelieva Tract Balloon Dilation SystemApril 19, 2019