THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE

THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE is an FDA 510(k)-cleared medical device (K112468) manufactured by Regulatory Specialists, Inc.. 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 October 19, 2011. Regulation: 8.