510(k) K060323

ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 by Boston Scientific Corporation — Product Code MQR

K060323 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380". The FDA issued a decision of Substantially Equivalent on May 12, 2006. The device falls under product code MQR (Stent, Colonic, Metallic, Expandable), a Class II device regulated under 21 CFR 878.3610. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.