510(k) K180182

Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter by Cook Incorporated — Product Code EYB

K180182 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter". The FDA issued a decision of Substantially Equivalent on September 14, 2018. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130. Cook Incorporated has at least 10 other 510(k) clearances on record.