510(k) Report

Devices descending from K170107

7 later devices reach Surgi Max Ultra through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC20195—
+1K170054iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America20170—
+2K254220Reusable 3 Button Fingerswitch WandSoniquence, LLC20260—
+2K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC20221—
+2K220071Soniquence Reusable Neutral PlateSoniquence, LLC20220—
+2K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips…Ellusa, LLC20201—
+3K222425Ellusa Reusable Neutral PlatesEllusa, LLC20220—