Balloon, Nasal Airway
The Balloon, Nasal Airway is an ENT device intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or to temporarily address nasal obstruction by inflating within the nasal passage. It is classified as FDA Class 1 (though requiring 510(k) based on submission type), under regulation 874.4420 in the Ear, Nose, and Throat specialty. The product code is QGK. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QGK
- Device Class
- FDA class 1
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K183090 | Relieva Tract Balloon Dilation System | Apr 19, 2019 | Substantially Equivalent | Acclarent, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.