DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682

DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682 is an FDA 510(k)-cleared medical device (K041827) manufactured by Boston Scientific Corp. 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 August 5, 2004. Regulation: 8.