510(k) K172057

Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set by Cook Ireland, Ltd. — Product Code FGE

K172057 is an FDA 510(k) premarket notification submitted by Cook Ireland, Ltd. for the device "Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set". The FDA issued a decision of Substantially Equivalent on March 9, 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, Ltd. has at least 10 other 510(k) clearances on record.