Data / Medical devices / Sweden / Episurf Operations AB
Episurf Operations AB: FDA-registered device maker in Stockholm, Sweden, 1 510(k) clearance
Episurf Operations AB is registered with the FDA (registration 3015341893) in Stockholm, Sweden. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 23, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015341893
- Address
- Karlavagen 60, Stockholm, Sweden, 11449
- Owner or operator
- Episurf Operations AB (10087531)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 11, 2023
- Registered through
- 2026
- Brand names listed
- Episealer® Patellofemoral System, EpisurfView, Femoral Adjustment Socket, Femoral Component, Femoral Drilling Socket, Femoral Epidrill, Femoral Epidummy, Femoral Epiguide and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | 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 |
|---|---|---|---|---|---|---|
| December 23, 2022 | K221048 | Episealer Patellofemoral System | KRR | Substantially Equivalent | Episurf Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Updated December 23, 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.