About This 510(k) Submission
K171969 is an FDA 510(k) clearance for the Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket, a Dislodger, Stone, Biliary (Class II — Special Controls, product code LQR), submitted by Wilson-Cook Medical, Inc. (Winstrom-Salem, US). The FDA issued a Cleared decision on March 28, 2018, 271 days after receiving the submission on June 30, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.