510(k) K180868

Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set by Cook Ireland — Product Code FGE

K180868 is an FDA 510(k) premarket notification submitted by Cook Ireland for the device "Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set". The FDA issued a decision of Substantially Equivalent on July 6, 2018. 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 Ireland has at least 10 other 510(k) clearances on record.