510(k) K183400 ยท NEU Marker, Radiographic, Implantable
EnVisio Navigation Sytem
| Applicant | Elucent Medical, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Mar 22, 2019 |
| Received | Dec 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183400
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2025 | Elucent Medical Inc 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 med Open, Classified |
NEU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.