GYNECOLOGY STERILIZATION TRAY

GYNECOLOGY STERILIZATION TRAY is an FDA 510(k)-cleared medical device (K121904) manufactured by Smith & Nephew Inc., Endoscopy Division. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 2013. Regulation: 8.