510(k) Report

Devices descending from K951489

8 later devices reach Mri's All Silicone Gastrostomy Tube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962375Microvasive Balloon Gastrostomy Tube KitBoston Scientific Corp19967—
+2K083685Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285Mri Manufacturing and Research, Inc.20093—
+2K083684Endo Vive Standard Replacement Gastrostomy Tube, Model 82XXManufacturing & Research, Inc.20092—
+3K130674Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices20142—
+3K130611Entuit Thrive Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices20131—
+4K180708Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP…Xeridiem Medical Devices, A Spectrum Plastics Group Company20181—
+4K171347Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit…Xeridiem Medical Devices20170—
+5K232046Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT…Xeridiem Medical Devices, A Spectrum Plastics Group Company20230—