510(k) Report

Devices descending from K820164

8 later devices reach Empty Sterile Carpuject through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083583Xpresse Injection SystemNordson Efd20091—
+1K081241Weigao Empty Cartridge SyringeShandong Weigao Group Medical Polymer Co., Ltd.20080—
+1K063180Isecure Syringe Cartridge HolderHospira, Inc.20065—
+1K042314Syringe Grip for the Avonex Pre-Filled SyringeBiogen20040—
+2K180345Uroject12 Syringe LeverUrogen Pharma, Ltd.20182—
+2K131963Tautona Injector DeviceTautona Group, LLC20130—
+3K190987Uroject12 Syringe LeverUrogen Pharma, Ltd.20191—
+4K203321Cystoject Syringe LeverUrogen Pharma, Ltd.20200—