ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380

ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 is an FDA 510(k)-cleared medical device (K060323) manufactured by Boston Scientific Corporation. 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 May 11, 2006. Regulation: 8.