DeviceClearance

Product code QGK— Ear, Nose, Throat

Relieva Tract Balloon Dilation System

Classification name
Balloon, Nasal Airway
Device class
Class 1
Regulation
21 CFR 874.4420
Advisory panel
Ear, Nose, Throat
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QGK under 21 CFR 874.4420, via openFDA

Market context for product code QGK

FDA has cleared 1 device under product code QGK, all in 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code QGK

Recent clearances under product code QGK

Data sourced from openFDA. This site is unofficial and independent of the FDA.