510(k) K161221

Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug by Cook Biotech Incorporated — Product Code FTM

K161221 is an FDA 510(k) premarket notification submitted by Cook Biotech Incorporated for the device "Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug". The FDA issued a decision of Substantially Equivalent on May 26, 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.