510(k) Report

Devices descending from K980913

153 later devices reach Cryo-Hit Model Numbers EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072883Ice-SenseArbel Medical, Ltd.200726—
+1K060390Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd.2006288
+1K991517Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5Galil Medical, Ltd.1999125—
+1K991272Cryo-Hit,Models ED1TO, Epiti, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3…Galil Medical, Ltd.199929—
+2K141485Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation NeedleGalil Medical, Ltd.201433
+2K121251Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd.2012221
+2K113860Visual-Ice Cryoablation SystemGalil Medical, Inc.2012152
+2K102360Icesence 3IceCure Medical, Ltd.2010251
+2K090978UC-Care Warming SystemUC-CARE, Ltd.20090—
+2K030518Ameritek Sure-Point Tracker SystemAmertek Medical, Inc.20030—
+2K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.200192—
+2K993965Cryo-HitGalil Medical, Ltd.2000123—
+3K230551Visual-ICE Cryoablation SystemBoston Scientific Corporation20234—
+3K183213IceSense 3, ProSense, MultiSenseIceCure Medical, Ltd.20193—
+3K181741IceSphere 1.5 CX Cryoablation NeedleGalil Medical, Ltd.201821
+3K181153ICEfx Cryoablation SystemGalil Medical, Inc.20180—
+3K152133IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit…Galil Medical, Ltd.20151318
+3K143564Visual-ICE Cryoablation System, Software Revision 1.3.1Galil Medical, Inc.2015101
+3K133258Trufreeze SystemCSA Medical, Inc.2014201
+3K140584Icerod CX Cryoablation NeedleGalil Medical, Ltd.201420—
+3K123865Visual-Ice Cryoablation SystemGalil Medical, Inc.2013111
+3K082954Encage Bipolar RF ProbeTrod Medical SA20080—
+3K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+3K022894Epicor Medical Ablation SystemEpicor Medical, Inc.200423—
+3K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc.200290—
+3K012497Cryo-Hit, Models EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, and EP2T1Galil Medical, Ltd.2001291
+4K250742Focused Cryotherapy SystemFocused Cryo, Inc.20250—
+4K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle…Boston Scientific Corp20240—
+4K240892XSense Cryoablation System with CryoprobesIceCure Medical, Ltd.20242—
+4K234002ICEfx Cryoablation System (FPRCH8000-02)Boston Scientific202402
+4K231661CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd.20230—
+4K232635IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)Boston Scientific202311
+4K203032IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle…Galil Medical, Inc.20200—
+4K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical, Ltd.201612
+4K161480R2 Dermal Cooling SystemR2 Dermatology20165—
+4K153489Cryocare CS Surgical SystemHealthtronics20165—
+4K143625truFreeze SystemCSA Medical, Inc.2015191
+4K110117Atricure Bipolar SystemAtriCure, Inc.20115—
+4K080292Epicor Ablation SystemSt Jude Medical200812
+4K043579Atricure Bipolar SystemAtriCure, Inc.200718—
+4K063630Atricure Ablation SystemAtriCure, Inc.20077—
+4K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2006221
+4K052893Atricure Transpolar SystemAtriCure, Inc.20058—
+4K050459Atricure Isolator Transpolar PenAtriCure, Inc.2005181
+4K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc.200422—
+4K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc.200442—
+4K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular200334—
+5K260377XSense Cryoablation System with CryoProbesIceCure Medical, Ltd.20260—
+5K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+5K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+5K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.20212—
+5K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.20212—
+5K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc.20204—
+5K171398Dermal Cooling SystemR2 Dermatology,Inc20174—
+5K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+5K152668truFreeze SystemCSA Medical, Inc.201510—
+5K150920truFreeze SystemCSA Medical, Inc.201511—
+5K121878Cardioblate Cryoflex Surgical Ablation ProbesMedtronic, Inc.20122—
+5K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc.20106—
+5K100501Multifunctional Linear PenAtriCure, Inc.20109—
+5K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc.2009161
+5K082279Epicor Ablation Control System, Model Acs-US-2, Acs-Eur-2St Jude Medical20080—
+5K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc.200810—
+5K073605Atricure Coolrail Linear PenAtriCure, Inc.200813—
+5K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist…Intuitive Surgical, Inc.200801
+5K070288Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814Medtronic Vascular20072—
+5K060346Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB20060—
+5K062539Ncontact Coagulation System KitNcontact Surgical, Inc.20060—
+5K060054Oncobionic SystemOncobionics, Inc.200614—
+5K062140Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1Cryocath Technologies, Inc.20061—
+5K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc.2006131
+5K060400Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation…Medtronic, Inc.200614—
+6K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.20250—
+6K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.20240—
+6K230271ISOLIS CryoprobeVarian Medical Systems, Inc.20231—
+6K201260Dermal Cooling SystemR2 Technologies, Inc.20203—
+6K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc.20191—
+6K190623Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation DeviceMedtronic20190—
+6K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+6K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+6K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+6K160273truFreeze SystemCsa Medial, Inc.20169—
+6K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc.20149—
+6K142441cryoICE croablation probeAtriCure, Inc.20141—
+6K130521Isolator Linear PenAtriCure, Inc.20133—
+6K123733Cardioblate Cryoflex Surgical Ablation SystemMedtronic, Inc.201315
+6K122611Coolrail Linear Pen Model McriAtriCure, Inc.20123—
+6K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc.201221
+6K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech201245
+6K111042Atricure Cryo ModuleAtriCure, Inc.201114—
+6K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc.20103—
+6K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+6K080287Oncobionic Bipolar ElectrodeAngioDynamics, Inc.20080—
+6K080202Oncobionic System with 6 Probe OutputOncobionics, Inc.2008111
+6K081082U-Clip Uni-Fire, Model M65Medtronic, Inc.20080—
+6K080376Oncobionic SystemOncobionic Incorporated2008111
+6K070311Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261Medtronic Vascular20071—
+6K062057U-Clip Device, Model NC65Medtronic Vascular20062—
+7K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.20240—
+7K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical…Medtronic, Inc.20220—