510(k) K233939

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System by Boston Scientific — Product Code ESW

K233939 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System". The FDA issued a decision of Substantially Equivalent on April 29, 2024. The device falls under product code ESW (Prosthesis, Esophageal), a Class II device regulated under 21 CFR 878.3610. Boston Scientific has at least 10 other 510(k) clearances on record.