510(k) Report

Devices descending from K993138

5 later devices reach Ballard Mic-Key G Low Profile Gastrostomy Replacement Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122653Mic-Key SF Low Profile Gastrostomy Tube and AccessoriesKimberly-Clark Corporation201331
+1K041034Skin Level Gastrostomy Tube Kit (Ecsl)Entracare, LLC20040—
+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—