ENDOCAM Flex HD Camera System 5521

ENDOCAM Flex HD Camera System 5521 is an FDA 510(k)-cleared medical device (K161204) manufactured by Richard Wolf Medical Instruments 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 January 10, 2017. Regulation: 8.