510(k) Report

Devices descending from K063538

40 later devices reach Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+1K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+1K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+2K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+2K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+2K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+2K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+2K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+2K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+2K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+3K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+3K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+3K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+3K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+3K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+3K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+3K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+3K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+3K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+3K121678DTADGyrus Acmi, Inc.20122—
+3K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+3K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+4K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+4K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+4K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+4K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+4K170908PK AIMGyrus Acmi, Inc.20170—
+4K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+4K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+4K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+4K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+4K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+5K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+5K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+5K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+5K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+5K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+5K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+5K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+6K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—