About This 510(k) Submission
K141344 is an FDA 510(k) clearance for the EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM, a Stent, Ureteral (Class II — Special Controls, product code FAD), submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on October 17, 2014, 148 days after receiving the submission on May 22, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4620.