510(k) K042065

WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM by Boston Scientific Corp — Product Code MQR

K042065 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 30, 2004. The device falls under product code MQR (Stent, Colonic, Metallic, Expandable), a Class II device regulated under 21 CFR 878.3610. Boston Scientific Corp has at least 10 other 510(k) clearances on record.