EVIS EXERA 160A SYSTEM

EVIS EXERA 160A SYSTEM is an FDA 510(k)-cleared medical device (K051645) manufactured by Olympus Medical Systems Corporation. 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 October 12, 2005. Regulation: 8.