FDA product code QGK

Balloon, Nasal Airway

Ear, Nose, Throat·Class 1·21 CFR 874.4420
US regulatory classifications
US Product Code (FDA)
QGK
View Product Code Classification →
US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 874.4420
View CFR Regulation →
Medical specialty
Ear, Nose, Throat
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

Search keywords
About this record

Balloon, Nasal Airway is a medical device type in the Ear, Nose, Throat specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.