510(k) K150668

Biodesign Enterocutaneous Fistula Plug by Cook Biotech Incorprated — Product Code FTM

K150668 is an FDA 510(k) premarket notification submitted by Cook Biotech Incorprated for the device "Biodesign Enterocutaneous Fistula Plug". The FDA issued a decision of Substantially Equivalent on December 9, 2015. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Cook Biotech Incorprated has at least 3 other 510(k) clearances on record.