About This 510(k) Submission
K213185 is an FDA 510(k) clearance for the ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits, a Stent, Ureteral (Class II — Special Controls, product code FAD), submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on June 8, 2022, 252 days after receiving the submission on September 29, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4620.