510(k) Report

Devices descending from K163161

9 later devices reach Sterile Single-use Syringe with Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221777Disposable Sterile SyringeWeihai Shengjie Medical Technology Co., Ltd.20230—
+1K211482Disposable Syringe with NeedleShandong Qinkai Medical Industry Co., Ltd.20220—
+1K211728Sterile hypodermic syringes for single useJiangsu Kangyou Medical Instrument Co., Ltd.20210—
+1K200242StaClear SyringeTribofilm Research, Inc.20205—
+2K243027Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27…Hangzhou Sightnovo Medical Technology Co., Ltd.20250—
+2K243936StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc.20251—
+2K243149Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)Congruence Medical Solutions, LLC20240—
+2K230372VitreJect SyringeOcuject, LLC20230—
+3K251849StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc.20250—