510(k) Report

Devices descending from K142113

5 later devices reach ESOPHYX2 HD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with…Endogastric Solutions, Inc.20172—
+1K143645EsophyX® Z Fastener Delivery DeviceEndogastric Solutions, Inc.20154—
+2K172811EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc.20171—
+2K160960EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.20163—
+3K240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.202402