510(k) Report

Devices descending from K960255

45 later devices reach Ceramic Blade Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233002Beed 2,5, Beed 3,8Excelsior Resources, LLC20240—
+1K150824TD-WandTdm Surgitech, Inc.20150—
+1K081791E-Z Clean Electrosurgical ElectrodeMegadyne Medical Products, Inc.200881
+1K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model…Peak Surgical, Inc.200833—
+2K240868Ultravision2™ IonPencilAlesi Surgical Limited20240—
+2K220725HPR45iF Care Systems USA, LLC20231—
+2K210338Edge Insulated Blade ElectrodeCovidien, LLC20210—
+2K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0Medtronic Advanced Energy20183—
+2K091672Disposable Grounding Pad Series and Electrode SeriesShuyou Electric Medical Science Co., Ltd.20093—
+2K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+2K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc.2008241
+3K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC20250—
+3K193579PlasmaBlade X 3.0S LIGHTMedtronic Navigation20202—
+3K160366Electrosurgical disposable grounding padsTop-Rank Health Care Co., Ltd.20160—
+3K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+3K152059Disposable General ElectrodeModern Medical Equipment Manufacturing Limited20161—
+3K160041Cobbra RF Tissue DissectorElliquence, LLC20166—
+3K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+3K142410Elliquence ElectrodesElliquence, LLC20157—
+3K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+3K143175AEx Generator; PlasmaBlade TMedtronic Advanced Energy20141—
+3K121881Domain Surgical SystemDomain Surgical, Inc.20124—
+3K121678DTADGyrus Acmi, Inc.20122—
+3K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+3K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+3K102029Peak Pulsar II Generator Model PS100-102Peak Surgical, Inc.20100—
+3K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc.20108—
+4K242266PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments20241—
+4K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC20195—
+4K171707GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1AGowoonsesang Cosmetics Co., Ltd.20170—
+4K170610PlasmaBlade TMedtronic Advanced Energy20170—
+4K162053PhotonBladeInvuity, Inc.201611
+4K130606Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc.20143—
+4K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+5K254220Reusable 3 Button Fingerswitch WandSoniquence, LLC20260—
+5K250483PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments20250—
+5K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC20221—
+5K220071Soniquence Reusable Neutral PlateSoniquence, LLC20220—
+5K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+5K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips…Ellusa, LLC20201—
+5K191583PhotonBlade with Smoke EvacuationInvuity, Inc.20200—
+5K141484Open FmsealerDomain Surgical, Inc.201411
+5K140384Fmwand Handpiece SEDomain Surgical, Inc.20140—
+6K222425Ellusa Reusable Neutral PlatesEllusa, LLC20220—
+6K142229Laparoscopic FMsealerDomain Surgical, Inc.20150—