510(k) K190659

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 by Allwin Medical Devices, Inc. — Product Code FAD

K190659 is an FDA 510(k) premarket notification submitted by Allwin Medical Devices, Inc. for the device "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". The FDA issued a decision of Substantially Equivalent (kit) on December 2, 2019. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Allwin Medical Devices, Inc. has at least 6 other 510(k) clearances on record.