Data / Medical devices / United Kingdom / Energist Limited
Energist Limited: FDA-registered device maker in Swansea, United Kingdom, 2 510(k) clearances
Energist Limited is registered with the FDA (registration 3007353760) in Swansea, United Kingdom. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated January 12, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007353760
- Address
- 2 Park Pavilions, Clos Llyn Cwm Enterprise Park, Swansea, United Kingdom, SA6 8QY
- Owner or operator
- Energist Limited (10027469)
- Roles
- Manufacturer
- First device listed
- January 9, 2014
- Registered through
- 2026
- Brand names listed
- NeoGen PSR System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 12, 2023 | K221873 | NeoGen PSR System | GEI | Substantially Equivalent | Energist Limited | accessdata.fda.gov |
| December 12, 2013 | K132754 | NEOGEN PSR SYSTEM | GEI | Substantially Equivalent | Energist, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 12, 2023. 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.