510(k) K201000

Biodesign Staple Line Reinforcement by Cook Biotech Incorporated — Product Code FTM

K201000 is an FDA 510(k) premarket notification submitted by Cook Biotech Incorporated for the device "Biodesign Staple Line Reinforcement". The FDA issued a decision of Substantially Equivalent on July 13, 2020. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Cook Biotech Incorporated has at least 10 other 510(k) clearances on record.