510(k) Report

Devices descending from K180345

2 later devices reach Uroject12 Syringe Lever through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190987Uroject12 Syringe LeverUrogen Pharma, Ltd.20191—
+2K203321Cystoject Syringe LeverUrogen Pharma, Ltd.20200—