510(k) Report

Devices descending from K083685

3 later devices reach Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130674Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices20142—
+2K180708Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP…Xeridiem Medical Devices, A Spectrum Plastics Group Company20181—
+3K232046Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT…Xeridiem Medical Devices, A Spectrum Plastics Group Company20230—