510(k) Report

Devices descending from K013921

2 later devices reach Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2X through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213185ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop…Coloplast Corp.20220—
+1K180469ImaJin Silicone Hydro-Coated Double Loop Ureteral StentColoplast Corp.20180—