510(k) K181971

Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set by Cook Incorporated — Product Code FAD

K181971 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set". The FDA issued a decision of Substantially Equivalent (kit) on April 23, 2019. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Cook Incorporated has at least 10 other 510(k) clearances on record.