DEN220025 is an FDA 510(k) submission for the Phagenyx System. This device is classified as a Oropharyngeal Electrical Stimulator (Class II - Special Controls, product code QQG).
Submitted by Phagenesis Limited (Manchester, GB). The FDA issued a Not Cleared (DENG) decision on September 16, 2022.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.5950. 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..
| 510(k) Number | DEN220025 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 19, 2022 |
| Decision Date | September 16, 2022 |
| Days to Decision | 150 days |
| Submission Type | Direct |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | - |
| Product Code | QQG - Oropharyngeal Electrical Stimulator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.5950 |
| 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. |