510(k) K053202

GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL by W.L. Gore & Associates — Product Code FTL

K053202 is an FDA 510(k) premarket notification submitted by W.L. Gore & Associates for the device "GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL". The FDA issued a decision of Substantially Equivalent on December 7, 2005. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. W.L. Gore & Associates has at least 2 other 510(k) clearances on record.