510(k) K201159

WallFlex Colonic Stent System with Anchor Lock Delivery System by Boston Scientific Corporation — Product Code MQR

K201159 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "WallFlex Colonic Stent System with Anchor Lock Delivery System". The FDA issued a decision of Substantially Equivalent on August 17, 2020. 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.