510(k) Report

Devices descending from K161994

10 later devices reach Aerin Medical Stylus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162810InSeca ARC Stylus, Aerin ConsoleAerin Medical, Inc.20179—
+2K260255AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)Aventix Medical, Inc.20260—
+2K242630Aerin ConsoleAerin Medical, Inc.20240—
+2K192471RHIN1 StylusAerin Medical, Inc.20194—
+2K172529Vivaer ARC StylusAerin Medical, Inc.20171—
+3K212666Neuromark SystemNeurent Medical20213—
+3K200300VivAer StylusAerin Medical, Inc.202001
+4K222032NEUROMARK SystemNeurent Medical20222—
+5K250048NEUROMARK System (NMK00301)Neurent Medical, Ltd.20251—
+6K261833NEUROMARK System (NMK00301)Neurent Medical, Ltd.20260—