510(k) Report

Devices descending from K921104

6 later devices reach Lopez Valve with NG Sump Tube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040388Next Generation Salem SumpKendall20045—
+2K150711Salem Sump Dual Lumen Stomach Tube with Multi-functional PortCovidien20153—
+2K053410Gientriport with Universal Single Lumen AdaptorKendall20060—
+3K190923Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth201921
+4K222846AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc.20230—
+4K213174Salem Sump Silicone Dual Lumen Stomach Tube with ENFit ConnectionCardinalhealth20220—