ULTRAFLEX PRECISION COLONIC STENT

ULTRAFLEX PRECISION COLONIC STENT is an FDA 510(k)-cleared medical device (K030769) manufactured by Boston Scientific Corp. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 2003. Regulation: 8.