510(k) Report

Devices descending from K870705

62 later devices reach Thermal Coagulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013873Cobra Cardiac Electrosurgical SystemBoston Scientific Corp200261—
+2K043579Atricure Bipolar SystemAtriCure, Inc.200718—
+2K053326Estech Cobra Electrosurgical Unit & CableEndoscopic Technologies, Inc.20067—
+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—
+2K040219Cobra Surgical ProbeBoston Scientific Corp20040—
+2K023288Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies200346—
+3K110117Atricure Bipolar SystemAtriCure, Inc.20115—
+3K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc.20106—
+3K080292Epicor Ablation SystemSt Jude Medical200812
+3K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc.200810—
+3K060346Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB20060—
+3K063012Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc.20066—
+3K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2006221
+3K053100Estech Cobra Bipolar SystemEndoscopic Technologies, Inc.20052—
+3K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc.200442—
+4K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+4K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.20212—
+4K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.20212—
+4K190623Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation DeviceMedtronic20190—
+4K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+4K121878Cardioblate Cryoflex Surgical Ablation ProbesMedtronic, Inc.20122—
+4K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc.201221
+4K100224Estech Cobra Bipolsr IIEndoscopic Technologies, Inc. D/B/A Estech20101—
+4K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc.20103—
+4K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+4K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc.2009161
+4K082203Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022; CSK-023; CSK-025Ncontact Surgical, Inc.20084—
+4K082279Epicor Ablation Control System, Model Acs-US-2, Acs-Eur-2St Jude Medical20080—
+4K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist…Intuitive Surgical, Inc.200801
+4K071819Ncontact Visitrax Guided Coagulation System Kit, Models CSK-212 and CSK-515Ncontact Surgical, Inc.20074—
+4K062140Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1Cryocath Technologies, Inc.20061—
+5K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.20250—
+5K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.20240—
+5K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical…Medtronic, Inc.20220—
+5K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic202011
+5K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+5K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc.20149—
+5K142441cryoICE croablation probeAtriCure, Inc.20141—
+5K133017Estech Cobra (R) Genesis Bipolar ClampEstech, Inc.20130—
+5K123733Cardioblate Cryoflex Surgical Ablation SystemMedtronic, Inc.201315
+5K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+5K111042Atricure Cryo ModuleAtriCure, Inc.201114—
+5K090202Numeris Guided Coagulation System with Visitrax, Models CSK-121, -122, -123 and -125Ncontact Surgical, Inc.20093—
+6K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.20240—
+6K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+6K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc.20190—
+6K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc.20184—
+6K180137AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation…AtriCure, Inc.20180—
+6K152337cryoFORM cryoICE cryoablation probeAtriCure, Inc.20162—
+6K140058Atricure Cryo Module SystemAtriCure, Inc.2014102
+6K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20122—
+6K112072Atricure Cryo Module SystemAtriCure, Inc.201113—
+7K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…Medinice S.A.20260—
+7K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…AtriCure, Inc.20202—
+7K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc.20183—
+7K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+7K133672Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyStryker Sustainability Solutions20140—
+7K121507Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc.201211—
+8K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.20250—
+8K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…AtriCure, Inc.20230—
+8K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—