510(k) Report

Devices descending from P040002

8 later devices reach Endologix Powerlink System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110090Afx Introducer SystemEndologix, Inc.20117—
+2K111747Endologix Afx Introducer SystemEndologix, Inc.20116—
+3K120212Afx Introducer SystemEndologix, Inc.20125Class I
+4K141275Endophys Pressure Sensing Sheath KitEndophys, Inc.20154—
+5K160272Endophys Pressure Sensing Sheath KitEndophys, Inc.20163—
+6K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC20180—
+6K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC20171—
+7K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC20190—