COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003

COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 is an FDA 510(k)-cleared medical device (K090485) manufactured by Percutaneous Systems, Incorporated. 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 July 21, 2009. Regulation: 8.