# DEN220025: Phagenyx System

- Pathway: De Novo (Direct)
- Applicant: Phagenesis Limited
- Decided: Sep 16, 2022 after 150 days
- Product code: QQG (Oropharyngeal Electrical Stimulator)
- Device class: 2
- Regulation: 21 CFR 874.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Phagenyx System is a neurostimulation device delivering electrical stimulation to the oropharynx, to be used in addition to standard dysphagia care, as an aid to improve swallowing in patients with severe dysphagia post stroke.

Source page: https://510kreport.com/device/DEN220025
Methodology: https://510kreport.com/methodology