Embozene Color-Advanced Microspheres

Embozene Color-Advanced Microspheres is an FDA 510(k)-cleared medical device (K180102) manufactured by Boston Scientific. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 18, 2018. Regulation: 8.