510(k) Report

Devices descending from K000501

171 later devices reach Electrosurgical Generator, Model S1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K102329Nanoknife SystemAngioDynamics, Inc.2011101
+6K112072Atricure Cryo Module SystemAtriCure, Inc.201113—
+6K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+6K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+6K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems20090—
+6K062821U-Clip DeviceMedtronic Neurosurgery20060—
+7K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…Medinice S.A.20260—
+7K240376Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.20240—
+7K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+7K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+7K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…AtriCure, Inc.20202—
+7K190587Coolrail Linear PenAtriCure, Inc.20191—
+7K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+7K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc.20183—
+7K163373PK AIMGyrus Acmi, Inc.20161—
+7K150089NanoKnife SystemAngioDynamics, Inc.201581
+7K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+7K133672Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyStryker Sustainability Solutions20140—
+7K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+7K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+7K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+7K121507Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc.201211—
+7K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+7K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+7K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+7K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+8K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.20250—
+8K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…AtriCure, Inc.20230—
+8K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+8K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+8K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—
+8K183385NanoKnife SystemAngiodynamics201971
+8K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+8K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+8K170908PK AIMGyrus Acmi, Inc.20170—
+8K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+8K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+8K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+8K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+8K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+8K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+8K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+8K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+8K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+8K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+9K253846Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…Hangzhou Ruidi Biotechnology, Ltd.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—
+9K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+9K212871Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) ElectrodeGalvanize Therapeutics, Inc.20222—
+9K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+9K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+9K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+9K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+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—
+10K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+10K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+10K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+11K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+12K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+13K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+13K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+14K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+14K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+14K201398SINUSPRIME Dilation SystemStryker Ent20200—
+14K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+15K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+15K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+16K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—