510(k) K191696

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft by Cook Biotech Incorporated — Product Code OXN

K191696 is an FDA 510(k) premarket notification submitted by Cook Biotech Incorporated for the device "Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft". The FDA issued a decision of Substantially Equivalent on December 27, 2019. The device falls under product code OXN (Mesh, Surgical, Collagen, Fistula), a Class II device regulated under 21 CFR 878.3300. Cook Biotech Incorporated has at least 10 other 510(k) clearances on record.