510(k) Report

Devices descending from K180708

1 later device reach Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232046Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT…Xeridiem Medical Devices, A Spectrum Plastics Group Company20230—