HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L

HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L is an FDA 510(k)-cleared medical device (K090980) manufactured by Olympus Winter & Ibe GmbH. 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 June 28, 2009. Regulation: 8.