EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1

EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1 is an FDA 510(k)-cleared medical device (K043487) manufactured by Aizu Olympus Co., Ltd.. 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 January 27, 2005. Regulation: 8.