510(k) K213186

NovoFlow Reinforced Ureteral Stent by Coloplast Corp. — Product Code FAD

K213186 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "NovoFlow Reinforced Ureteral Stent". The FDA issued a decision of Substantially Equivalent (kit) on February 16, 2022. 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.