510(k) K260119 ยท OVB Hydrogel Spacer
SpaceOAR Vue System (SV-2101)
| Applicant | Boston Scientific Corporation, Marborough MA, US |
| Decision | Substantially Equivalent, Feb 10, 2026 |
| Received | Jan 14, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260119
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.