510(k) Report

Devices descending from K100390

10 later devices reach Surgimax/ Surgimax Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171869Sutter CURIS RF GeneratorSutter Medizintechnik GmbH20181—
+1K170107Surgi Max UltraElliquence, LLC20177—
+2K251813CURIS II RF Generator (REF 360100-05)Sutter Medizintechnik GmbH20260—
+2K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC20195—
+2K170054iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America20170—
+3K254220Reusable 3 Button Fingerswitch WandSoniquence, LLC20260—
+3K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC20221—
+3K220071Soniquence Reusable Neutral PlateSoniquence, LLC20220—
+3K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips…Ellusa, LLC20201—
+4K222425Ellusa Reusable Neutral PlatesEllusa, LLC20220—