510(k) K131201

ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET by Cook, Inc. — Product Code FGE

K131201 is an FDA 510(k) premarket notification submitted by Cook, Inc. for the device "ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET". The FDA issued a decision of Substantially Equivalent on October 7, 2013. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Cook, Inc. has at least 10 other 510(k) clearances on record.