SpaceOAR Vue System (SV-2101)

SpaceOAR Vue System (SV-2101) is an FDA 510(k)-cleared medical device (K260119) manufactured by Boston Scientific Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 9, 2026. Regulation: 8.