510(k) K162109

Kwart Retro-Inject Ureteral Stent by Cook Incorporated — Product Code FAD

K162109 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Kwart Retro-Inject Ureteral Stent". The FDA issued a decision of Substantially Equivalent on Jun 7, 2017. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Cook Incorporated has 174 other 510(k) clearances on record.