510(k) Report

Devices descending from K111747

6 later devices reach Endologix Afx Introducer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120212Afx Introducer SystemEndologix, Inc.20125Class I
+2K141275Endophys Pressure Sensing Sheath KitEndophys, Inc.20154—
+3K160272Endophys Pressure Sensing Sheath KitEndophys, Inc.20163—
+4K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC20180—
+4K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC20171—
+5K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC20190—