510(k) Report

Devices descending from K043114

5 later devices reach Kimberly-Clark Mic-Key Low Profile Gastrostomy Tube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142297Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S…Xeridiem (Formerly Mri)20150104
+1K122653Mic-Key SF Low Profile Gastrostomy Tube and AccessoriesKimberly-Clark Corporation201331
+2K173955Mic-Key* SF Over-the-Wire Stoma Measuring DeviceHalyard Health, Inc.20180—
+2K161413Low Profile Balloon Feeding DeviceApplied Medical Technology, Inc.20171—
+3K222846AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc.20230—