510(k) K180557

Greene Renal Transplant Stent Set by Cook Incorporated — Product Code FAD

K180557 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Greene Renal Transplant Stent Set". The FDA issued a decision of Substantially Equivalent on November 23, 2018. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Cook Incorporated has at least 10 other 510(k) clearances on record.