About This 510(k) Submission
K190659 is an FDA 510(k) clearance for the Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip, a Stent, Ureteral (Class II — Special Controls, product code FAD), submitted by Allwin Medical Devices, Inc. (Anaheim, US). The FDA issued a Cleared decision on December 2, 2019, 263 days after receiving the submission on March 14, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4620.