510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QGKClass I

Balloon, Nasal Airway

21 CFR 874.4420 / Ear, Nose, Throat
FDA source (opens on fda.gov)

QGK is the FDA product code for Balloon, Nasal Airway, a class I device type, regulated under 21 CFR 874.4420. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QGK
Device name
Balloon, Nasal Airway
FDA 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.
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QGK

By decision year
1 clearance under product code QGK with a decision year between 2019 and 2019, 2019 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QGK by decision year
YearClearances
20191

Applicants with the most clearances

Product code QGK
Applicants holding the most 510(k) clearances under product code QGK
ApplicantClearances
Acclarent Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code