510(k) K162934

Biodesign Parastomal Hernia Repair Graft by Cook Biotech Incorporated — Product Code FTM

K162934 is an FDA 510(k) premarket notification submitted by Cook Biotech Incorporated for the device "Biodesign Parastomal Hernia Repair Graft". The FDA issued a decision of Substantially Equivalent on July 10, 2017. 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.