510(k) Report

Devices descending from K210227

2 later devices reach Sterile syringe for single use with/without needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213811Sterile Hypodermic Syringes for Single UseBerpu Medical Technology Co., Ltd.20221—
+2K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.20260—