510(k) Report

Devices descending from K031247

34 later devices reach Cardioblate Bipolar Radiofrequency Surgical Ablation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070288Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814Medtronic Vascular20072—
+1K062539Ncontact Coagulation System KitNcontact Surgical, Inc.20060—
+1K060054Oncobionic SystemOncobionics, Inc.200614—
+1K060400Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation…Medtronic, Inc.200614—
+2K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+2K080287Oncobionic Bipolar ElectrodeAngioDynamics, Inc.20080—
+2K080202Oncobionic System with 6 Probe OutputOncobionics, Inc.2008111
+2K081082U-Clip Uni-Fire, Model M65Medtronic, Inc.20080—
+2K080376Oncobionic SystemOncobionic Incorporated2008111
+2K070311Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261Medtronic Vascular20071—
+2K063630Atricure Ablation SystemAtriCure, Inc.20077—
+2K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+2K062057U-Clip Device, Model NC65Medtronic Vascular20062—
+3K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+3K102329Nanoknife SystemAngioDynamics, Inc.2011101
+3K110117Atricure Bipolar SystemAtriCure, Inc.20115—
+3K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc.20106—
+3K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems20090—
+3K062821U-Clip DeviceMedtronic Neurosurgery20060—
+4K240376Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.20240—
+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—
+4K150089NanoKnife SystemAngioDynamics, Inc.201581
+5K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.20250—
+5K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.20240—
+5K183385NanoKnife SystemAngiodynamics201971
+6K253846Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…Hangzhou Ruidi Biotechnology, Ltd.20260—
+6K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…AngioDynamics, Inc.20241—
+6K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd.20230—
+6K212871Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) ElectrodeGalvanize Therapeutics, Inc.20222—
+7K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20260—
+7K253198NanoKnife Generator (H78720300351US0)Angiodynamics20260—
+7K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20241—