510(k) Report

Devices descending from K014297

16 later devices reach Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161003EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector…Boston Scientific Corporation201611
+1K083685Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285Mri Manufacturing and Research, Inc.20093—
+1K083684Endo Vive Standard Replacement Gastrostomy Tube, Model 82XXManufacturing & Research, Inc.20092—
+1K030855Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety KitBoston Scientific Corp200362
+2K191844Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd.20190—
+2K133087Abbvie PegAbbVie, Inc.20141—
+2K130674Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices20142—
+2K130611Entuit Thrive Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices20131—
+2K031538Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety KitBoston Scientific Corp2003321
+3K180708Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP…Xeridiem Medical Devices, A Spectrum Plastics Group Company20181—
+3K171347Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit…Xeridiem Medical Devices20170—
+3K150679EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial…Boston Scientific Corp201503
+3K142793AbbVie PEGAbbVie, Inc.201504
+3K061021Entake Standard and Safety Peg SystemConmedcorp2006128
+4K232046Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT…Xeridiem Medical Devices, A Spectrum Plastics Group Company20230—
+4K182248Aspire Venting TubeAspire Bariatrics, Inc.20180—