510(k) Report

Devices descending from K021777

76 later devices reach Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+1K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+1K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+2K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+2K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+2K142289PK SpatulaGyrus Acmi, Inc.20141—
+2K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+2K121678DTADGyrus Acmi, Inc.20122—
+2K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+2K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+2K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+2K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+2K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+2K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+2K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+3K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+3K161038PK MorcellatorGyrus Acmi, Inc.20160—
+3K142350PK J-HookGyrus Acmi, Inc.201511
+3K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+3K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+3K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+3K122605PKS BillGyrus Acmi, Inc.20121—
+3K102366Finess EndoscopeEntellus Medical, Inc.20110—
+3K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+3K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+3K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+3K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+3K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+4K161825PK AIMGyrus Acmi, Inc.20162—
+4K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+4K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+4K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+5K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+5K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+5K163373PK AIMGyrus Acmi, Inc.20161—
+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—
+6K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+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—
+6K170908PK AIMGyrus Acmi, Inc.20170—
+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—