Data / Medical devices / United States / Elucent Medical Inc.
Elucent Medical Inc.: FDA-registered device maker in Eden Prairie, MN, United States, 3 510(k) clearances
Elucent Medical Inc. is registered with the FDA (registration 3014653199) in Eden Prairie, MN, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 20, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014653199
- Address
- 6509 Flying Cloud Drive Suite 160, Eden Prairie, MN, United States, 55344
- Owner or operator
- Elucent Medical Inc. (10057977)
- Roles
- Manufacturer, Specification developer
- First device listed
- June 20, 2018
- Registered through
- 2027
- Brand names listed
- EnVisio System, SmartClip Secure Soft Tissue Marker, SmartClip Soft Tissue Marker, SmartSensor, SmartSurface Riser - Stryker D860, SmartSurface Riser - Trumpf TS7000
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Marker, Radiographic, Implantable | NEU | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Table And Attachments, Operating-Room | BWN | 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 20, 2024 | K233639 | SmartClip Secure Soft Tissue Marker | NEU | Substantially Equivalent | Elucent Medical, Inc. | accessdata.fda.gov |
| March 22, 2019 | K183400 | EnVisio Navigation Sytem | NEU | Substantially Equivalent | Elucent Medical, Inc. | accessdata.fda.gov |
| June 4, 2018 | K180640 | SmartClip Soft Tissue Marker | NEU | Substantially Equivalent | Elucent Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 18, 2024 | 95902 | Class II | Ongoing | EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that det | There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System. | accessdata.fda.gov |
Compare with other makers
Updated January 6, 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.