510(k) K040119

PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION by Synovis Surgical Innovations — Product Code FTM

K040119 is an FDA 510(k) premarket notification submitted by Synovis Surgical Innovations for the device "PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION". The FDA issued a decision of Substantially Equivalent on March 17, 2004. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Synovis Surgical Innovations has at least 7 other 510(k) clearances on record.