Data / Medical devices / United Kingdom / Phagenesis Limited
Phagenesis Limited: FDA-registered device maker in Manchester Lancashire, United Kingdom, 1 510(k) clearance
Phagenesis Limited is registered with the FDA (registration 3014265054) in Manchester Lancashire, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 16, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014265054
- Address
- Unit 18 Enterprise House Manchester Science Park, Manchester Lancashire, United Kingdom, M156SE
- Owner or operator
- Phagenesis Limited (10086158)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 15, 2022
- Registered through
- 2026
- Brand names listed
- The Phagenyx System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oropharyngeal Electrical Stimulator | QQG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2022 | DEN220025 | Phagenyx System | QQG | Unknown | Phagenesis Limited | accessdata.fda.gov |
Updated September 16, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.