QQG · Class II · 21 CFR 874.5950

FDA Product Code QQG: Oropharyngeal Electrical Stimulator

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.

Leading manufacturers include Phagenesis Limited.

1
Total
0
Cleared
150d
Avg days
2022
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Oropharyngeal Electrical Stimulator Devices (Product Code QQG)

1 devices
1–1 of 1
Not Cleared Sep 16, 2022
Phagenyx System
DEN220025
Phagenesis Limited
Ear, Nose, Throat · 150d

About Product Code QQG - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QQG since 2022, with 0 receiving FDA clearance (average review time: 150 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QQG devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →