510(k) Report

Devices descending from K030108

92 later devices reach Arthrocare Ent Coblator Surgery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+1K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+1K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+1K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+1K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+1K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+2K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+2K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+2K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+2K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+2K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+2K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+2K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+2K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+2K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+2K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+2K121678DTADGyrus Acmi, Inc.20122—
+2K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+2K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+2K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+2K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+3K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+3K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+3K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+3K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+3K170908PK AIMGyrus Acmi, Inc.20170—
+3K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+3K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+3K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+3K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+3K102366Finess EndoscopeEntellus Medical, Inc.20110—
+3K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+3K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+3K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+4K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+4K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+4K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+4K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+4K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+4K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+4K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+4K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+4K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+4K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+4K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+4K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+5K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+5K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+5K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+5K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+5K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+5K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+5K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+5K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+5K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+5K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+5K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+5K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+5K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+5K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+6K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+6K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+6K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+6K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+6K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+6K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+6K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+6K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+6K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+6K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+6K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+6K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+6K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+7K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+7K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+7K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+7K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+7K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+8K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+8K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+8K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+9K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+10K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+11K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+11K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+12K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+12K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+12K201398SINUSPRIME Dilation SystemStryker Ent20200—
+12K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+13K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+13K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+14K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—