510(k) K161277

ConvertX Nephroureteral Stent System by Brightwater Medical — Product Code FAD

K161277 is an FDA 510(k) premarket notification submitted by Brightwater Medical for the device "ConvertX Nephroureteral Stent System". The FDA issued a decision of Substantially Equivalent on Nov 22, 2016. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Brightwater Medical has 1 other 510(k) clearance on record.