510(k) Report

Devices descending from K061126

3 later devices reach Accurex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090607Blue Sky Bio Plan, Version .38Blue Sky Bio, LLC20092—
+2K190096R2GATEMegagen Implant Co., Ltd.20191—
+3K223909R2GATE Lite TMMegagen Implant Co., Ltd.20230—