VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010

VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 is an FDA 510(k)-cleared medical device (K092107) manufactured by Nidacon International AB. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 14, 2010. Regulation: 8.