510(k) K201436

Vortek Single Loop Ureteral Stent by Coloplast Corp. — Product Code FAD

K201436 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "Vortek Single Loop Ureteral Stent". The FDA issued a decision of Substantially Equivalent on February 25, 2021. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Coloplast Corp. has at least 10 other 510(k) clearances on record.