QGK · Class I — Low Risk (general controls) · Ear, Nose, Throat · 21 CFR 874.4420
Classification
FDA Product Code
QGK
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 874.4420
Review panel
EN
Medical specialty
Ear, Nose, Throat
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.