TIPCAM 1S 3D System

TIPCAM 1S 3D System is an FDA 510(k)-cleared medical device (K162880) manufactured by Karl Storz Endoscopy America, 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 March 15, 2017. Regulation: 8.