Data / Medical devices / United Kingdom / Emblation Limited
Emblation Limited: FDA-registered device maker in Stirling, United Kingdom, 6 510(k) clearances
Emblation Limited is registered with the FDA (registration 3010933564) in Stirling, United Kingdom. It lists 1 device type. The FDA files 6 510(k) clearances under its listings, the newest dated August 8, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010933564
- Address
- Emblation House Castle Business Park, Stirling, United Kingdom, FK9 4TS
- Owner or operator
- Emblation Limited (10048070)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
- First device listed
- December 3, 2014
- Registered through
- 2026
- Brand names listed
- Emprint Ablation System with Thermosphere Technology, Swift® System, swiftPro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Ablation, Microwave And Accessories | NEY | 2 | Complaint file establishment, Exporter to the US, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| August 8, 2025 | K250718 | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | NEY | Substantially Equivalent | Emblation Limited | accessdata.fda.gov |
| April 23, 2024 | K240518 | swiftPro System | NEY | Substantially Equivalent | Emblation Limited | accessdata.fda.gov |
| May 4, 2023 | K222388 | swiftPro System | NEY | Substantially Equivalent | Emblation , Ltd. | accessdata.fda.gov |
| August 26, 2020 | K200796 | Emprint Ablation System with Thermosphere Technology | NEY | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| October 18, 2018 | K181941 | Swift System | NEY | Substantially Equivalent | Emblation , Ltd. | accessdata.fda.gov |
| April 28, 2014 | K133821 | EMPRINT ABLATION SYSTEM | NEY | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
Compare with other makers
Updated August 8, 2025. 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.