510(k) Report

Devices descending from K130674

2 later devices reach Entuit Thrive LP Balloon Retention Gastrostomy Feeding Tube through their predicates, nearest generation first.

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