510(k) Report

Devices descending from K013901

30 later devices reach Malleable Surgical Lightstic 180, Model 180 (1CM-9CM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052495Atrilaze Malleable Ablation ProbeMedical Cv, Inc.20054—
+1K041739Edwards E360 Surgical Ablation DeviceEdwards Lifesciences, LLC20040—
+1K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc.200422—
+1K022894Epicor Medical Ablation SystemEpicor Medical, Inc.200423—
+2K080292Epicor Ablation SystemSt Jude Medical200812
+2K043579Atricure Bipolar SystemAtriCure, Inc.200718—
+2K061489Atrilaze MI Surgical Ablation SystemMedical Cv, Inc.20071—
+2K060346Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB20060—
+2K060680Atrilaze Surgical Ablation SystemMedical Cv, Inc.20063—
+3K110117Atricure Bipolar SystemAtriCure, Inc.20115—
+3K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc.20106—
+3K082409Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000…Endophotonix, Inc.20090—
+3K082279Epicor Ablation Control System, Model Acs-US-2, Acs-Eur-2St Jude Medical20080—
+3K081457Atrilaze Laser Ablation SystemMedical Cv, Inc.20081—
+3K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc.200810—
+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—
+4K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc.201221
+4K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc.20103—
+4K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+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
+5K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+6K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—