510(k) Report

Devices descending from K013463

134 later devices reach Arthrocare Arthro Wands, Enetec Evac Plasma Wand through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+1K041810Serfas Energy SystemStryker Endoscopy2004173
+1K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+1K020557Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsArthrocare Corp.200255—
+2K173741Reprocessed ArthoCare Ablation WandRenovo, Inc.20180—
+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—
+2K071859Stryker Crossfire SystemStryker Endoscopy200742
+2K052686Arthrocare ArthrowandsArthrocare Corp.200526—
+2K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+2K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+2K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+2K030551Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control…Arthrocare Corp.2003521
+2K021519Arthrocare Controller, Authrocare Cable, Foot Control, Power Cord, WandsArthrocare Corp.20021—
+3K252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC20250—
+3K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+3K173740Reprocessed DePuy Mitek Ablation WandRenovo, Inc.20180—
+3K171391Stryker 90-S Max SERFAS Energy ProbeStryker20180—
+3K162770Relign SystemRelign Corporation20172—
+3K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+3K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation201632
+3K143475VAPR Tripolar Suction ElectrodeDepuy Mitek201501
+3K142289PK SpatulaGyrus Acmi, Inc.20141—
+3K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company20140—
+3K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+3K121678DTADGyrus Acmi, Inc.20122—
+3K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+3K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+3K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+3K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+3K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+3K070958Modification to Arthrocare ArthrowandsArthrocare Corp.200722—
+3K053567Athrocare Topaz ArthrowandsArthrocare Corp.200621
+3K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+3K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+3K032223Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic Intermittent…Cook Vascular, Inc.20030—
+3K032504Arthrocare SystemArthrocare Corp.200351—
+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—
+4K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+4K161038PK MorcellatorGyrus Acmi, Inc.20160—
+4K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation201623
+4K142350PK J-HookGyrus Acmi, Inc.201511
+4K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+4K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+4K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+4K122605PKS BillGyrus Acmi, Inc.20121—
+4K102366Finess EndoscopeEntellus Medical, Inc.20110—
+4K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+4K090393Arthrocare System 15000 Contoller, Model 72202149, Arthrocare Arthrowands, Model…Arthrocare Corp.20091—
+4K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+4K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+4K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+4K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+4K080282Arthrocare Controllers (System 2000,1100,1200), Model H2076-00, H2079-00, H3000-00…Arthrocare Corp.200811
+4K071709Arthrocare System 12000Arthrocare Corp.200715—
+4K071963Modification to: Arthrocare ArthrowandsArthrocare Corp.200721—
+4K033584Arthrocare ArthrowandsArthrocare Corp.2003431
+5K251899E BlatorNew Deantronics Taiwan, Ltd.20250—
+5K161825PK AIMGyrus Acmi, Inc.20162—
+5K153675Paragon T2 Wand with Integrated CableArthroCare Corporation20160—
+5K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+5K140521Topaz EZ Microdebrider Coblation Wand with Integrated Finger SwitchArthroCare Corporation20140—
+5K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+5K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+5K093165Arthrocare System 15000 Controller, ArthrowandsArthrocare Corp.20090—
+5K082666Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power…Arthrocare Corp.200812—
+5K072865Modificaton to: Arthrocare ArthrowandsArthrocare Corp.200720—
+5K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+6K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System…ArthroCare Corporation20221—
+6K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+6K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+6K163373PK AIMGyrus Acmi, Inc.20161—
+6K161581Arthrex Synergy RF SystemArthrex, Inc.20160—
+6K143235RF20000a Controller, FLOW 50 WandArthroCare Corporation20154—
+6K140578Arthroscopic Energy SystemConmed Corporation201411
+6K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+6K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+6K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+6K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+6K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+6K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+6K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+6K082323Arthrocare ArthrowandsArthrocare Corp.200819—
+7K242907DELPHI SystemCnS Medical Co., Ltd.20250—
+7K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+7K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+7K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+7K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+7K170908PK AIMGyrus Acmi, Inc.20170—
+7K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+7K162074Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation20163—
+7K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+7K153499EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy…Conmed Corporation20150—
+7K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+7K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+7K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—