CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX

CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX is an FDA 510(k)-cleared medical device (K080946) manufactured by Conmed Endoscopic Technologies, Inc.. 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 May 19, 2008. Regulation: 8.