510(k) Report

Devices descending from K162475

6 later devices reach mi-eye 2, mi-eye 2 monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233115Hawkeye Control Unit with Eyas EndoscopeE Surgical, LLC20240—
+1K212556mi-eye 3 needlescope with cannula, mi-tablet 3Trice Medical, Inc.20210—
+1K191345Pegasus SystemA.M. Surgical, Inc.20190—
+1K181982MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc.20182—
+2K243020MIDASVuIntravu, Inc.20241—
+3K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.20260—