510(k) Report

Devices descending from K000501

171 later devices reach Electrosurgical Generator, Model S1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020067Gyrus Ent Somnoplasty GeneratorGyrus Ent LLC200277—
+1K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.200192—
+2K082954Encage Bipolar RF ProbeTrod Medical SA20080—
+2K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+2K022894Epicor Medical Ablation SystemEpicor Medical, Inc.200423—
+2K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+2K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc.200290—
+3K110117Atricure Bipolar SystemAtriCure, Inc.20115—
+3K080292Epicor Ablation SystemSt Jude Medical200812
+3K043579Atricure Bipolar SystemAtriCure, Inc.200718—
+3K063630Atricure Ablation SystemAtriCure, Inc.20077—
+3K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2006221
+3K052893Atricure Transpolar SystemAtriCure, Inc.20058—
+3K050459Atricure Isolator Transpolar PenAtriCure, Inc.2005181
+3K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+3K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+3K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc.200422—
+3K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc.200442—
+3K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+3K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular200334—
+4K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+4K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+4K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.20212—
+4K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.20212—
+4K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+4K142289PK SpatulaGyrus Acmi, Inc.20141—
+4K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+4K121878Cardioblate Cryoflex Surgical Ablation ProbesMedtronic, Inc.20122—
+4K121678DTADGyrus Acmi, Inc.20122—
+4K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+4K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc.20106—
+4K100501Multifunctional Linear PenAtriCure, Inc.20109—
+4K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+4K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc.2009161
+4K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+4K082279Epicor Ablation Control System, Model Acs-US-2, Acs-Eur-2St Jude Medical20080—
+4K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc.200810—
+4K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+4K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+4K073605Atricure Coolrail Linear PenAtriCure, Inc.200813—
+4K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist…Intuitive Surgical, Inc.200801
+4K070288Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814Medtronic Vascular20072—
+4K060346Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB20060—
+4K062539Ncontact Coagulation System KitNcontact Surgical, Inc.20060—
+4K060054Oncobionic SystemOncobionics, Inc.200614—
+4K062140Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1Cryocath Technologies, Inc.20061—
+4K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc.2006131
+4K060400Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation…Medtronic, Inc.200614—
+4K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+4K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+5K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.20250—
+5K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.20240—
+5K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+5K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc.20191—
+5K190623Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation DeviceMedtronic20190—
+5K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+5K161038PK MorcellatorGyrus Acmi, Inc.20160—
+5K142350PK J-HookGyrus Acmi, Inc.201511
+5K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc.20149—
+5K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+5K142441cryoICE croablation probeAtriCure, Inc.20141—
+5K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+5K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+5K130521Isolator Linear PenAtriCure, Inc.20133—
+5K123733Cardioblate Cryoflex Surgical Ablation SystemMedtronic, Inc.201315
+5K122605PKS BillGyrus Acmi, Inc.20121—
+5K122611Coolrail Linear Pen Model McriAtriCure, Inc.20123—
+5K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc.201221
+5K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech201245
+5K111042Atricure Cryo ModuleAtriCure, Inc.201114—
+5K102366Finess EndoscopeEntellus Medical, Inc.20110—
+5K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+5K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc.20103—
+5K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+5K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+5K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+5K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+5K080287Oncobionic Bipolar ElectrodeAngioDynamics, Inc.20080—
+5K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+5K080202Oncobionic System with 6 Probe OutputOncobionics, Inc.2008111
+5K081082U-Clip Uni-Fire, Model M65Medtronic, Inc.20080—
+5K080376Oncobionic SystemOncobionic Incorporated2008111
+5K070311Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261Medtronic Vascular20071—
+5K062057U-Clip Device, Model NC65Medtronic Vascular20062—
+6K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.20240—
+6K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical…Medtronic, Inc.20220—
+6K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic202011
+6K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc.20190—
+6K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+6K190151COBRA Fusion Ablation SystemAtriCure, Inc.20190—
+6K183065Coolrail Linear PenAtriCure, Inc.20182—
+6K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc.20184—
+6K180137AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation…AtriCure, Inc.20180—
+6K163408Isolator Multifunctional Linear PenAtriCure, Inc.20172—
+6K161825PK AIMGyrus Acmi, Inc.20162—
+6K152337cryoFORM cryoICE cryoablation probeAtriCure, Inc.20162—
+6K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+6K140058Atricure Cryo Module SystemAtriCure, Inc.2014102
+6K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20122—
+6K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—