510(k) Report

Devices descending from K110090

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111747Endologix Afx Introducer SystemEndologix, Inc.20116—
+2K120212Afx Introducer SystemEndologix, Inc.20125Class I
+3K141275Endophys Pressure Sensing Sheath KitEndophys, Inc.20154—
+4K160272Endophys Pressure Sensing Sheath KitEndophys, Inc.20163—
+5K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC20180—
+5K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC20171—
+6K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC20190—