510(k) K082682

SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG by Cook Biotech, Inc. — Product Code FTM

K082682 is an FDA 510(k) premarket notification submitted by Cook Biotech, Inc. for the device "SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG". The FDA issued a decision of Substantially Equivalent on February 27, 2009. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Cook Biotech, Inc. has at least 10 other 510(k) clearances on record.