About This 510(k) Submission
K171043 is an FDA 510(k) clearance for the Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters, a Catheter, Ureteral, Gastro-urology (Class II — Special Controls, product code EYB), submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on December 21, 2017, 258 days after receiving the submission on April 7, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.