510(k) Report

Devices descending from K063180

5 later devices reach Isecure Syringe Cartridge Holder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180345Uroject12 Syringe LeverUrogen Pharma, Ltd.20182—
+1K083583Xpresse Injection SystemNordson Efd20091—
+2K190987Uroject12 Syringe LeverUrogen Pharma, Ltd.20191—
+2K131963Tautona Injector DeviceTautona Group, LLC20130—
+3K203321Cystoject Syringe LeverUrogen Pharma, Ltd.20200—