TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING

TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING is an FDA 510(k)-cleared medical device (K040129) 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 February 26, 2004. Regulation: 8.