Data / Medical devices / United States / Emblation Inc.
Emblation Inc.: FDA-registered device maker in Lincoln, RI, United States, 3 510(k) clearances
Emblation Inc. is registered with the FDA (registration 3015152398) in Lincoln, RI, United States. It lists 1 device type. The FDA files 3 510(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
- 3015152398
- Address
- 42 Albion Rd, Lincoln, RI, United States, 02865
- Owner or operator
- Emblation Inc. (10059260)
- Roles
- Complaint file establishment
- First device listed
- June 8, 2026
- Registered through
- 2026
- Brand names listed
- swiftPro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Ablation, Microwave And Accessories | NEY | 2 | Complaint file establishment | 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 |
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.