510(k) Report

Devices descending from K973618

82 later devices reach Somnoplasty System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032838Celon Ent SystemCelon AG Medical Instruments20033—
+1K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+1K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+2K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus…Olympus Winter & Ibe GmbH20250—
+2K191732Sutter RaVoR Bipolar ElectrodesSutter Medizintechnik GmbH20190—
+2K160639Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH20160—
+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—
+3K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+3K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+3K142289PK SpatulaGyrus Acmi, Inc.20141—
+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—
+3K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+3K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+4K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+4K161038PK MorcellatorGyrus Acmi, Inc.20160—
+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
+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—
+5K161825PK AIMGyrus Acmi, Inc.20162—
+5K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+5K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+5K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+6K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+6K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+6K163373PK AIMGyrus Acmi, Inc.20161—
+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—
+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—
+7K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+7K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+7K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+7K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+7K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+7K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+7K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+7K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+7K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+8K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+8K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+8K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+8K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+8K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+9K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+9K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+9K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+10K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+11K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+12K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+12K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+13K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+13K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+13K201398SINUSPRIME Dilation SystemStryker Ent20200—
+13K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+14K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+14K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+15K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—