510(k) K173035

Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets by Cook Incorporated — Product Code FGE

K173035 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets". The FDA issued a decision of Substantially Equivalent on May 1, 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 Incorporated has 174 other 510(k) clearances on record.