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

Oropharyngeal Electrical Stimulator

21 CFR 874.5950 / Ear, Nose, Throat
FDA source (opens on fda.gov)

QQG is the FDA product code for Oropharyngeal Electrical Stimulator, a class II device type, regulated under 21 CFR 874.5950. FDA's definition for this code reads: "An oropharyngeal electrical stimulator is a device that stimulates afferent nerve fibers of oropharyngeal mucosa. The device is intended to treat swallowing dysfunction. The device may incorporate a feeding tube". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QQG
Device name
Oropharyngeal Electrical Stimulator
FDA definition
An oropharyngeal electrical stimulator is a device that stimulates afferent nerve fibers of oropharyngeal mucosa. The device is intended to treat swallowing dysfunction. The device may incorporate a feeding tube.
Regulation
21 CFR 874.5950
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QQG

By decision year
1 clearance under product code QQG with a decision year between 2022 and 2022, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QQG by decision year
YearClearances
20221

Applicants with the most clearances

Product code QQG
Applicants holding the most 510(k) clearances under product code QQG
ApplicantClearances
Phagenesis Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code