510(k) K160869

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft by Cook Biotech Incorporated — Product Code FTM

K160869 is an FDA 510(k) premarket notification submitted by Cook Biotech Incorporated for the device "Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft". The FDA issued a decision of Substantially Equivalent on April 29, 2016. 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.