510(k) Report

Devices descending from K991273

5 later devices reach Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161970Follicle Aspiration SetVitrolife Sweden AB20170—
+1K112462Kitazato Opu NeedleKitazato Medical Co., Ltd.20121—
+1K082727Follicle Aspiration Set, Reduced Single LumenVitrolife Sweden AB20093—
+2K172050Follicle Aspiration Set, Reduced Single LumenVitrolife Sweden AB20170—
+2K162881Kitazato OPU NeedlesKitazato Corporation20170—