510(k) K200257

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

K200257 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System". The FDA issued a decision of Substantially Equivalent on April 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.