510(k) Report

Devices descending from K981981

47 later devices reach Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062539Ncontact Coagulation System KitNcontact Surgical, Inc.20060—
+1K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+1K051749Cobra Surgical SystemEstech, Inc.200519—
+1K022008Cardima Ablation SystemCardima, Inc.2003252
+1K023291Cobra Cooled Cardiac Surgical Probe, Model 1596XBoston Scientific Corp200225—
+2K150134Basic, Dominant Flex, KV-6Medela AG20152—
+2K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech201245
+2K110913Estech Cobra Surgical System with Thermashield AccessoryEndoscopic Technologies, Inc. D/B/A Estech20110—
+2K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc.2006131
+2K060715Modification to: Cardima Ablation SystemCardima, Inc.200602
+2K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc.200422—
+2K022894Epicor Medical Ablation SystemEpicor Medical, Inc.200423—
+2K032207Cobra Cooled Surgical Probe, Model M004159670Boston Scientific Corp20031—
+3K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc.20191—
+3K190151COBRA Fusion Ablation SystemAtriCure, Inc.20190—
+3K160950MiniscavSedation Systems, LLC201701
+3K170329Basic, Dominant FlexModela AG201701
+3K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20122—
+3K100501Multifunctional Linear PenAtriCure, Inc.20109—
+3K080292Epicor Ablation SystemSt Jude Medical200812
+3K043579Atricure Bipolar SystemAtriCure, Inc.200718—
+3K070288Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814Medtronic Vascular20072—
+3K060346Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB20060—
+3K040104Cobra Adhere Surgical System, Model M00415977C0Boston Scientific Corp20040—
+4K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+4K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+4K130521Isolator Linear PenAtriCure, Inc.20133—
+4K110117Atricure Bipolar SystemAtriCure, Inc.20115—
+4K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc.20106—
+4K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+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—
+5K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.20212—
+5K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.20212—
+5K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—
+5K190623Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation DeviceMedtronic20190—
+5K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+5K163408Isolator Multifunctional Linear PenAtriCure, Inc.20172—
+5K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc.201221
+5K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+5K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc.20103—
+6K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.20250—
+6K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.20240—
+6K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical…Medtronic, Inc.20220—
+6K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic202011
+6K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+7K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—