Product code QQG— Ear, Nose, Throat

Phagenyx System

Classification name: Oropharyngeal Electrical Stimulator
Device class: Class 2
Regulation: 21 CFR 874.5950
Advisory panel: Ear, Nose, Throat
Total cleared: 1
First cleared: 2022-09-16
Most recent: 2022-09-16

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code QQG under 21 CFR 874.5950, via openFDA

Market context for product code QQG

FDA has cleared 1 device under product code QQG, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QQG

Phagenesis Limited1 clearance

Recent clearances under product code QQG

DEN220025 — Phagenyx SystemPhagenesis Limited·2022-09-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.