510(k) Report

Devices descending from K910584

2 later devices reach One Step Button (TM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161003EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector…Boston Scientific Corporation201611
+2K191844Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd.20190—