510(k) Report

Devices descending from K061174

35 later devices reach Surgi-Max through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100390Surgimax/ Surgimax PlusElliquence, LLC201010—
+1K083352Veinwave, TC3000Newlands Clinical Trials, Ltd.20094—
+1K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc.2008241
+2K210077MED RF 4000F Care Systems USA, LLC20211—
+2K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0Medtronic Advanced Energy20183—
+2K171869Sutter CURIS RF GeneratorSutter Medizintechnik GmbH20181—
+2K170107Surgi Max UltraElliquence, LLC20177—
+2K160041Cobbra RF Tissue DissectorElliquence, LLC20166—
+2K142410Elliquence ElectrodesElliquence, LLC20157—
+2K143175AEx Generator; PlasmaBlade TMedtronic Advanced Energy20141—
+2K130283Evrf SystemF Care Systems NV20132—
+2K121881Domain Surgical SystemDomain Surgical, Inc.20124—
+2K112334Vein-Gogh InstrumentRefine USA, LLC20120—
+2K102029Peak Pulsar II Generator Model PS100-102Peak Surgical, Inc.20100—
+2K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc.20108—
+3K251813CURIS II RF Generator (REF 360100-05)Sutter Medizintechnik GmbH20260—
+3K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC20250—
+3K193579PlasmaBlade X 3.0S LIGHTMedtronic Navigation20202—
+3K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC20195—
+3K170054iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America20170—
+3K170610PlasmaBlade TMedtronic Advanced Energy20170—
+3K162053PhotonBladeInvuity, Inc.201611
+3K130606Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc.20143—
+3K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+4K254220Reusable 3 Button Fingerswitch WandSoniquence, LLC20260—
+4K242266PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments20241—
+4K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC20221—
+4K220071Soniquence Reusable Neutral PlateSoniquence, LLC20220—
+4K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips…Ellusa, LLC20201—
+4K191583PhotonBlade with Smoke EvacuationInvuity, Inc.20200—
+4K141484Open FmsealerDomain Surgical, Inc.201411
+4K140384Fmwand Handpiece SEDomain Surgical, Inc.20140—
+5K250483PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments20250—
+5K222425Ellusa Reusable Neutral PlatesEllusa, LLC20220—
+5K142229Laparoscopic FMsealerDomain Surgical, Inc.20150—