510(k) Report

Devices descending from K153584

8 later devices reach NeoTract UroLift System UL500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162345UroLift System UL500, UroLift Delivery Handle, UroLift Implant CartiridgeNeotract, Inc.20167—
+2K172359UroLift System (UL500)Neotract, Inc.20176—
+3K173087UroLift System (UL400 and UL500)Neotract, Inc.201751
+4K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeNeotract, Inc.20201—
+4K193269UroLift System (UL400)Neotract, Inc.201911
+4K190377UroLift System UL400Neotract, Inc.20190—
+5K232558UroLift 2 ATC Advanced Tissue Control SystemNeotract, Inc.20230—
+5K200441UroLift Advanced Tissue Control (ATC) SystemNeotract, Inc.20200—