510(k) K230671

Pitch PaSoft Tissue Reinforcement Device by Xiros, Ltd. — Product Code FTL

K230671 is an FDA 510(k) premarket notification submitted by Xiros, Ltd. for the device "Pitch PaSoft Tissue Reinforcement Device". The FDA issued a decision of Substantially Equivalent on May 31, 2023. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Xiros, Ltd. has at least 10 other 510(k) clearances on record.