510(k) Report

Devices descending from K162810

9 later devices reach InSeca ARC Stylus, Aerin Console through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260255AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)Aventix Medical, Inc.20260—
+1K242630Aerin ConsoleAerin Medical, Inc.20240—
+1K192471RHIN1 StylusAerin Medical, Inc.20194—
+1K172529Vivaer ARC StylusAerin Medical, Inc.20171—
+2K212666Neuromark SystemNeurent Medical20213—
+2K200300VivAer StylusAerin Medical, Inc.202001
+3K222032NEUROMARK SystemNeurent Medical20222—
+4K250048NEUROMARK System (NMK00301)Neurent Medical, Ltd.20251—
+5K261833NEUROMARK System (NMK00301)Neurent Medical, Ltd.20260—