TSolution One w/ACG+ Surgical System

TSolution One w/ACG+ Surgical System is an FDA 510(k)-cleared medical device (K153647) manufactured by THINK Surgical, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 15, 2016. Regulation: 8.