510(k) Report

Devices descending from K040690

42 later devices reach Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist…Intuitive Surgical, Inc.200801
+1K043579Atricure Bipolar SystemAtriCure, Inc.200718—
+1K062140Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1Cryocath Technologies, Inc.20061—
+1K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2006221
+2K121878Cardioblate Cryoflex Surgical Ablation ProbesMedtronic, Inc.20122—
+2K110117Atricure Bipolar SystemAtriCure, Inc.20115—
+2K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc.20106—
+2K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc.2009161
+2K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc.200810—
+3K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+3K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.20212—
+3K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.20212—
+3K190623Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation DeviceMedtronic20190—
+3K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+3K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc.20149—
+3K142441cryoICE croablation probeAtriCure, Inc.20141—
+3K123733Cardioblate Cryoflex Surgical Ablation SystemMedtronic, Inc.201315
+3K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc.201221
+3K111042Atricure Cryo ModuleAtriCure, Inc.201114—
+3K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc.20103—
+3K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+4K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.20250—
+4K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.20240—
+4K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.20240—
+4K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical…Medtronic, Inc.20220—
+4K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic202011
+4K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc.20190—
+4K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+4K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc.20184—
+4K180137AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation…AtriCure, Inc.20180—
+4K152337cryoFORM cryoICE cryoablation probeAtriCure, Inc.20162—
+4K140058Atricure Cryo Module SystemAtriCure, Inc.2014102
+4K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+4K112072Atricure Cryo Module SystemAtriCure, Inc.201113—
+5K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…Medinice S.A.20260—
+5K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+5K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…AtriCure, Inc.20202—
+5K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc.20183—
+5K133672Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyStryker Sustainability Solutions20140—
+5K121507Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc.201211—
+6K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.20250—
+6K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…AtriCure, Inc.20230—