510(k) K251557

Bard® Mesh; Bard® Mesh Pre-Shaped by Davol, Inc. — Product Code FTL

K251557 is an FDA 510(k) premarket notification submitted by Davol, Inc. for the device "Bard® Mesh; Bard® Mesh Pre-Shaped". The FDA issued a decision of Substantially Equivalent on June 12, 2025. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Davol, Inc. has at least 10 other 510(k) clearances on record.