510(k) Report

Devices descending from K121479

5 later devices reach AIM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141806Clear Guide OneClear Guide Medical20142—
+1K132744Acessa Guidance SystemHalt Medical, Inc.20141—
+2K211529NAVIRFA ScopeNavifus Corporation20220—
+2K202119AcuSee AS-P1000 SystemWeipeng (Suzhou) Medical Devices Co., Ltd.20200—
+2K181124Acessa ProVu SystemAcessa Health, Inc.20180—