AXCESS SOFT TIP WIRE GUIDE

AXCESS SOFT TIP WIRE GUIDE is an FDA 510(k)-cleared medical device (K122816) manufactured by Wilson-Cook Medical, 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 October 8, 2012. Regulation: 8.