K260119
- 510(k) number
- K260119
- Device name
- SpaceOAR Vue System (SV-2101)
- Applicant
- Boston Scientific Corporation MA · US
- Product code
- OVB — Hydrogel Spacer
- Decision date
- 2026-02-10
- Date received
- 2026-01-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K260119.pdf
Official FDA record: K260119
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.