510(k) Report

Devices descending from K163654

1 later device reach VersaOne fascial closure system bladed trocar, VersaOne fascial closure system… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260197Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)Suzhou Shenyun Medical Equipment Co., Ltd.20260—