510(k) Report

Devices descending from K970021

3 later devices reach Rusch Suprapubic Tray through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132890Suprapubic Catheter and Introducer SetMediplus, Ltd.20141—
+1K102572Iyunni 3ID Suprapubic Cystostomy Tube KitSainath Intellectual Properties, LLC20100—
+2K182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated20180—