510(k) Report

Devices descending from K192222

7 later devices reach EZ-Inject Single use Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210444EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc.20216—
+2K250284TSK SELECT™ NeedleTsk Laboratory, Japan20250—
+2K231734STERiJECT Low Dead Space, STERiJECT The Invisible NeedleTsk Laboratory International Japan KK20240—
+2K231165Shina Syringe; Shina Safety SyringeShina Med Corporation20230—
+2K221860PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc.20231—
+2K220083LDV ((Low Dead Volume )SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20220—
+3K241190PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc.20240—