510(k) Report

Devices descending from K040388

5 later devices reach Next Generation Salem Sump through their predicates, nearest generation first.

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