510(k) Report

Devices descending from K962935

30 later devices reach Unimed Coated Needle Electrode/Coated Blade Electrode/Coated Ball Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132224Unimed Surgical Coated Electrosurgical ElectrodesUnimed Surgical Products, Inc.20130—
+1K073616Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd.200825—
+1K970066Unimed Coated Laparoscopic/Arthroscopy/Suction-Irrigation ElectrodeUnimed Surgical Products, Inc.199731
+2K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc.2008241
+2K020579Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and AR03Aaron Medical Industries20021—
+3K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0Medtronic Advanced Energy20183—
+3K170703Single Use Arthroscopic Electrode (with Pencil)Modern Medical Equipment Manufacturing Limited20180—
+3K160041Cobbra RF Tissue DissectorElliquence, LLC20166—
+3K142410Elliquence ElectrodesElliquence, LLC20157—
+3K143175AEx Generator; PlasmaBlade TMedtronic Advanced Energy20141—
+3K121881Domain Surgical SystemDomain Surgical, Inc.20124—
+3K102029Peak Pulsar II Generator Model PS100-102Peak Surgical, Inc.20100—
+3K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc.20108—
+4K193579PlasmaBlade X 3.0S LIGHTMedtronic Navigation20202—
+4K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC20195—
+4K170610PlasmaBlade TMedtronic Advanced Energy20170—
+4K162053PhotonBladeInvuity, Inc.201611
+4K130606Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc.20143—
+4K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+5K254220Reusable 3 Button Fingerswitch WandSoniquence, LLC20260—
+5K242266PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments20241—
+5K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC20221—
+5K220071Soniquence Reusable Neutral PlateSoniquence, LLC20220—
+5K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips…Ellusa, LLC20201—
+5K191583PhotonBlade with Smoke EvacuationInvuity, Inc.20200—
+5K141484Open FmsealerDomain Surgical, Inc.201411
+5K140384Fmwand Handpiece SEDomain Surgical, Inc.20140—
+6K250483PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments20250—
+6K222425Ellusa Reusable Neutral PlatesEllusa, LLC20220—
+6K142229Laparoscopic FMsealerDomain Surgical, Inc.20150—