3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY

3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY is an FDA 510(k)-cleared medical device (K943307) manufactured by Olympus America, 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 December 19, 1995. Regulation: 8.