About This 510(k) Submission
K180182 is an FDA 510(k) clearance for the Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter, a Catheter, Ureteral, Gastro-urology (Class II — Special Controls, product code EYB), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on September 14, 2018, 234 days after receiving the submission on January 23, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.