510(k) Report

Devices descending from K122653

3 later devices reach Mic-Key SF Low Profile Gastrostomy Tube and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173955Mic-Key* SF Over-the-Wire Stoma Measuring DeviceHalyard Health, Inc.20180—
+1K161413Low Profile Balloon Feeding DeviceApplied Medical Technology, Inc.20171—
+2K222846AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc.20230—