510(k) Report

Devices descending from K981591

8 later devices reach Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop Stent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180057Vortek Ureteral Double Loop StentColoplast Corp.20182—
+1K170362Vortek Hydro-Coated Double Loop Ureteral StentsColoplast Corp.20174—
+1K170422Biosoft Duo Double Loop Ureteral StentsColoplast Corp.20170—
+1K013921Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2XPorges S.A.20022—
+2K213185ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop…Coloplast Corp.20220—
+2K213186NovoFlow Reinforced Ureteral StentColoplast Corp.20220—
+2K201436Vortek Single Loop Ureteral StentColoplast Corp.20210—
+2K180469ImaJin Silicone Hydro-Coated Double Loop Ureteral StentColoplast Corp.20180—