OBSIDIO™ Conformable Embolic (M0013972101010)

OBSIDIO™ Conformable Embolic (M0013972101010) is an FDA 510(k)-cleared medical device (K253376) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 29, 2025. Regulation: 8.