510(k) DEN220025
DEN220025 is an FDA 510(k) premarket notification submitted by Phagenesis Limited for the device "Phagenyx System". The FDA issued a decision of De Novo Granted on September 16, 2022. The device falls under product code QQG (Oropharyngeal Electrical Stimulator), a Class II device regulated under 21 CFR 874.5950.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 16, 2022
- Date Received
- April 19, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oropharyngeal Electrical Stimulator
- Device Class
- Class II
- Regulation Number
- 874.5950
- Review Panel
- EN
- Submission Type
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.