510(k) Report

Devices descending from K011083

156 later devices reach Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173741Reprocessed ArthoCare Ablation WandRenovo, Inc.20180—
+1K101711Ceruleau Electrosurgical ProbeNuortho Surgical, Inc.20100—
+1K053567Athrocare Topaz ArthrowandsArthrocare Corp.200621
+1K041810Serfas Energy SystemStryker Endoscopy2004173
+1K031371Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc.200319—
+1K013463Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp.2001134—
+2K172608Medline ReNewal Reprocessed Stryker SERF AS Energy ProbesSurgical Instrument Service and Savings, Inc.20170—
+2K160050SERFAS 90-S Electrosurgical ProbeStryker Corporation20161—
+2K121855Resprocessed Serfas Energy ProbeStryker Sustainability Solutions20120—
+2K113545Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II Electrosurgical System…Depuy Mitek, A Johnson & Johnson Company20127—
+2K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+2K080282Arthrocare Controllers (System 2000,1100,1200), Model H2076-00, H2079-00, H3000-00…Arthrocare Corp.200811
+2K071859Stryker Crossfire SystemStryker Endoscopy200742
+2K043442Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments200517—
+2K033652Minimally Invasive Solutions Osteotomy Guide InstrumentZimmer, Inc.20040—
+2K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+2K020557Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsArthrocare Corp.200255—
+3K252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC20250—
+3K173740Reprocessed DePuy Mitek Ablation WandRenovo, Inc.20180—
+3K171391Stryker 90-S Max SERFAS Energy ProbeStryker20180—
+3K162770Relign SystemRelign Corporation20172—
+3K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems20167—
+3K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation201632
+3K143475VAPR Tripolar Suction ElectrodeDepuy Mitek201501
+3K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company20140—
+3K140521Topaz EZ Microdebrider Coblation Wand with Integrated Finger SwitchArthroCare Corporation20140—
+3K070443Intracept BI-Polar RF Probe, Model 04814Relievant Medsystems, Inc.20072—
+3K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments20065—
+3K052686Arthrocare ArthrowandsArthrocare Corp.200526—
+3K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+3K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+3K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+3K030551Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control…Arthrocare Corp.2003521
+3K021519Arthrocare Controller, Authrocare Cable, Foot Control, Power Cord, WandsArthrocare Corp.20021—
+4K251802STAR RF Ablation SystemMerit Medical Systems, Inc.20260—
+4K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece…Relign Corporation, Subsidiary of Zimmer Biomet20240—
+4K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…Relign Corporation20231—
+4K231126Eblator DeviceE Surgical, LLC20231—
+4K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+4K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems20184—
+4K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems20174—
+4K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation201623
+4K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+4K142289PK SpatulaGyrus Acmi, Inc.20141—
+4K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+4K121678DTADGyrus Acmi, Inc.20122—
+4K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+4K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+4K083528Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc.20094—
+4K083856Intracept Flexible BI-Polar RF Probe and Curved Instrument Set, Models: FG0018, FG0026Relievant Medsystems, Inc.20090—
+4K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+4K082954Encage Bipolar RF ProbeTrod Medical SA20080—
+4K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+4K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+4K070958Modification to Arthrocare ArthrowandsArthrocare Corp.200722—
+4K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+4K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+4K032223Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic Intermittent…Cook Vascular, Inc.20030—
+4K032504Arthrocare SystemArthrocare Corp.200351—
+5K251899E BlatorNew Deantronics Taiwan, Ltd.20250—
+5K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+5K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve…Relievant Medsystems20193—
+5K161038PK MorcellatorGyrus Acmi, Inc.20160—
+5K142350PK J-HookGyrus Acmi, Inc.201511
+5K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+5K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+5K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+5K122605PKS BillGyrus Acmi, Inc.20121—
+5K111262Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters…Olsen Medical201232
+5K102366Finess EndoscopeEntellus Medical, Inc.20110—
+5K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+5K090393Arthrocare System 15000 Contoller, Model 72202149, Arthrocare Arthrowands, Model…Arthrocare Corp.20091—
+5K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+5K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+5K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+5K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+5K071709Arthrocare System 12000Arthrocare Corp.200715—
+5K071963Modification to: Arthrocare ArthrowandsArthrocare Corp.200721—
+5K033584Arthrocare ArthrowandsArthrocare Corp.2003431
+6K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN…Stryker Instruments20250—
+6K241621Da Vinci Monopolar and Bipolar Adapters (378896)Intuitive Surgical20240—
+6K213836Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.20221—
+6K161825PK AIMGyrus Acmi, Inc.20162—
+6K153675Paragon T2 Wand with Integrated CableArthroCare Corporation20160—
+6K143662Bissinger Monopolar Forceps and CablesMedagent, Inc.20150—
+6K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+6K133167Monopolar Cautery Cord, Bipolar Cautery CordIntuitive Surgical, Inc.20140—
+6K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+6K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+6K093165Arthrocare System 15000 Controller, ArthrowandsArthrocare Corp.20090—
+6K082666Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power…Arthrocare Corp.200812—
+6K072865Modificaton to: Arthrocare ArthrowandsArthrocare Corp.200720—
+6K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+7K222281Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.202201
+7K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System…ArthroCare Corporation20221—
+7K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+7K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+7K163373PK AIMGyrus Acmi, Inc.20161—
+7K161581Arthrex Synergy RF SystemArthrex, Inc.20160—
+7K143235RF20000a Controller, FLOW 50 WandArthroCare Corporation20154—