510(k) K262406

EluPro Antibiotic-Eluting BioEnvelope by Boston Scientific — Product Code FTM

K262406 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "EluPro Antibiotic-Eluting BioEnvelope". The FDA issued a decision of Substantially Equivalent on August 12, 2026. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Boston Scientific has at least 10 other 510(k) clearances on record.