510(k) Report

Devices descending from K945975

186 later devices reach Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K132232Mins Needlescopic Resposable Device SystemMinilap Technologies20130—
+5K132203Pneuview XE Veryclear Gas Evacuation CannulaLexion Medical, LLC20130—
+5K132169Surgiquest Airseal IfsSurgiquest, Inc.20130—
+5K130521Isolator Linear PenAtriCure, Inc.20133—
+5K123733Cardioblate Cryoflex Surgical Ablation SystemMedtronic, Inc.201315
+5K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation201231Class I
+5K122611Coolrail Linear Pen Model McriAtriCure, Inc.20123—
+5K120640Insuflow Synergy PortLexion Medical, LLC20125—
+5K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc.201221
+5K121336Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator…Surgiquest, Inc.20124—
+5K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech201245
+5K111042Atricure Cryo ModuleAtriCure, Inc.201114—
+5K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc.20103—
+5K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+5K080287Oncobionic Bipolar ElectrodeAngioDynamics, Inc.20080—
+5K080202Oncobionic System with 6 Probe OutputOncobionics, Inc.2008111
+5K081082U-Clip Uni-Fire, Model M65Medtronic, Inc.20080—
+5K080376Oncobionic SystemOncobionic Incorporated2008111
+5K070311Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261Medtronic Vascular20071—
+5K062057U-Clip Device, Model NC65Medtronic Vascular20062—
+6K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.20250—
+6K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation202501
+6K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.20240—
+6K221995Gas InsufflatorSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20230—
+6K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical…Medtronic, Inc.20220—
+6K201361PneumoclearW.O.M. World of Medicine GmbH202014—
+6K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic202011
+6K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc.20190—
+6K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+6K190151COBRA Fusion Ablation SystemAtriCure, Inc.20190—
+6K183065Coolrail Linear PenAtriCure, Inc.20182—
+6K172516SurgiQuest AIRSEAL iFS SystemConmed Corporation20188—
+6K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc.20184—
+6K180137AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation…AtriCure, Inc.20180—
+6K163408Isolator Multifunctional Linear PenAtriCure, Inc.20172—
+6K152337cryoFORM cryoICE cryoablation probeAtriCure, Inc.20162—
+6K140263Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC20142—
+6K140058Atricure Cryo Module SystemAtriCure, Inc.2014102
+6K132204Insuflow Synergy XL PortLexion Medical, LLC20133—
+6K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20122—
+6K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+6K102329Nanoknife SystemAngioDynamics, Inc.2011101
+6K112072Atricure Cryo Module SystemAtriCure, Inc.201113—
+6K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems20090—
+6K062821U-Clip DeviceMedtronic Neurosurgery20060—
+7K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG20260—
+7K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…Medinice S.A.20260—
+7K250388Endoflator +Karl Storz SE & CO. KG20251—
+7K240376Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.20240—
+7K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+7K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+7K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…AtriCure, Inc.20202—
+7K193520EVA 15 InsufflatorPalliare, Ltd.20205—
+7K190587Coolrail Linear PenAtriCure, Inc.20191—
+7K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc.20183—
+7K150089NanoKnife SystemAngioDynamics, Inc.201581
+7K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+7K133672Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyStryker Sustainability Solutions20140—
+7K121507Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc.201211—
+8K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+8K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+8K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+8K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+8K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+8K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.20250—
+8K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+8K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+8K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…AtriCure, Inc.20230—
+8K230474EVA5 InsufflatorPalliare, Ltd.20231—
+8K202799EVA15Palliare, Ltd.20204—
+8K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—
+8K183385NanoKnife SystemAngiodynamics201971
+9K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+9K253846Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…Hangzhou Ruidi Biotechnology, Ltd.20260—
+9K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+9K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.20260—
+9K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+9K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+9K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…AngioDynamics, Inc.20241—
+9K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd.20230—
+9K222901EVA15 insufflatorPalliare, Ltd.20233—
+9K212871Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) ElectrodeGalvanize Therapeutics, Inc.20222—
+10K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20260—
+10K253198NanoKnife Generator (H78720300351US0)Angiodynamics20260—
+10K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20241—
+10K232902EVA15 insufflatorPalliare, Ltd.20240—