510(k) Report

Devices descending from K063280

8 later devices reach Injekt Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101547Henke- Sass, Wolf Piston Syringe (Norm-Jet)Henke-Sass, Wolf GmbH20103—
+1K071459B. Braun Piston Syringes and Omnican and Omnifix Insulin SyringesB.Braun Medical, Inc.200732
+2K241385Omnifix Syringe NRFitB.Braun Medical, Inc.20240—
+2K202432MiniLoad SyringeOcuject, LLC20212—
+2K193101Omnifix Low Dead Space Luer Lock SyringeB.Braun Medical, Inc.20200—
+2K120127Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical SystemSwan Valley Medical, Incorporated20120—
+3K231558SMB Luer lock disposable syringeSmb Corporation of India20240—
+3K212544MiniLoad SyringeOcuject, LLC20210—