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
+7K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc.20212—
+7K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic202011
+7K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc.20190—
+7K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+7K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+7K190151COBRA Fusion Ablation SystemAtriCure, Inc.20190—
+7K183065Coolrail Linear PenAtriCure, Inc.20182—
+7K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc.20184—
+7K180137AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation…AtriCure, Inc.20180—
+7K163408Isolator Multifunctional Linear PenAtriCure, Inc.20172—
+7K161557truFreeze SystemCSA Medical, Inc.20168—
+7K152337cryoFORM cryoICE cryoablation probeAtriCure, Inc.20162—
+7K140058Atricure Cryo Module SystemAtriCure, Inc.2014102
+7K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20122—
+7K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+7K102329Nanoknife SystemAngioDynamics, Inc.2011101
+7K112072Atricure Cryo Module SystemAtriCure, Inc.201113—
+7K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems20090—
+7K062821U-Clip DeviceMedtronic Neurosurgery20060—
+8K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…Medinice S.A.20260—
+8K240376Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.20240—
+8K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+8K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+8K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…AtriCure, Inc.20202—
+8K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+8K190587Coolrail Linear PenAtriCure, Inc.20191—
+8K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc.20183—
+8K162695truFreeze SystemCSA Medical, Inc.20167—
+8K150089NanoKnife SystemAngioDynamics, Inc.201581
+8K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+8K133672Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyStryker Sustainability Solutions20140—
+8K121507Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc.201211—
+9K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+9K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.20250—
+9K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…AtriCure, Inc.20230—
+9K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+9K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—
+9K183385NanoKnife SystemAngiodynamics201971
+9K171522truFreeze Rapid AV Spray KitCSA Medical, Inc.20170—
+9K163244truFreeze SystemCSA Medical, Inc.20175—
+10K253846Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…Hangzhou Ruidi Biotechnology, Ltd.20260—
+10K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…AngioDynamics, Inc.20241—
+10K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—
+10K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd.20230—
+10K212871Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) ElectrodeGalvanize Therapeutics, Inc.20222—
+10K171626truFreeze SystemCSA Medical, Inc.20173—
+10K172041truFreeze SystemCSA Medical, Inc.20170—
+11K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20260—
+11K253198NanoKnife Generator (H78720300351US0)Angiodynamics20260—
+11K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20241—
+11K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20221—
+11K201183Vortex Radial Spray CatheterCSA Medical, Inc.20200—
+12K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20220—