OPSIS THORACOSCOPY VIDEO SYSTEM THORACICCAM AND THORACICCAM 360

OPSIS THORACOSCOPY VIDEO SYSTEM THORACICCAM AND THORACICCAM 360 is an FDA 510(k)-cleared medical device (K941950) manufactured by Baxter Healthcare Corp. 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 August 10, 1994. Regulation: 8.