510(k) Report

Devices descending from K014002

4 later devices reach All Silicone Supra-Pubia Catheter, Models 4880/4890 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181097Cook Cystostomy Catheter SetCook Incorporated20191—
+1K132890Suprapubic Catheter and Introducer SetMediplus, Ltd.20141—
+2K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc.20240—
+2K182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated20180—