510(k) Report

Devices descending from K911037

5 later devices reach Safety Needle Sheath, Modification through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073188Hypodermic Needle-Pro Edge Safety DeviceSmiths Medical Asd, Inc.20080—
+1K013006Ovus Capless Safety NeedleOvus Systems20020—
+1K012736Monoject Safety NeedleTyco Healthcare2001293
+2K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.20260—
+2K082908Novaguard, Model 3611001West Pharmaceutical Services, Inc.20090—