510(k) Report

Devices descending from K041970

2 later devices reach Biotop Hooksafe Safety Syringe, Models 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062318Biotop Hooksafe U-100 Insulin Syringe, Models 0.5CC/ML and 1CC/MLBiotop Technology Co., Ltd.20070—
+1K043038Biotop Hooksafe Luer-Lock Safety Syringe, Models 3CC/ML, 5CC/ML and 10CC/MLBiotop Technology Co., Ltd.20040—