510(k) Report

Devices descending from K952681

1,700 later devices reach Stryker Hummer II Microdebrider System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon Group20170—
+5K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+5K163565MR8 Drill SystemMedtronic Powered Surgical Solutions20177—
+5K161038PK MorcellatorGyrus Acmi, Inc.20160—
+5K162547Viveve SystemViveve, Inc.20166—
+5K161043Profound SystemSyneron Candela Corporation20160—
+5K161661Thermi RF AccessoriesThermi20163—
+5K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+5K153743Piezosurgery PlusMectron S.P.A.20162—
+5K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+5K151793InMode RF SystemInmode MD, Ltd.20161—
+5K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+5K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation201632
+5K152057OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20158—
+5K150728XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV PoleMedtronic Xomed, Inc.20150—
+5K143475VAPR Tripolar Suction ElectrodeDepuy Mitek201501
+5K142350PK J-HookGyrus Acmi, Inc.201511
+5K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+5K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC20149—
+5K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company20140—
+5K130755Hicut Highspeed InstrumentAdeor Medical AG20144—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+5K132264PRIMADO2 Total Surgical SystemNakanishi, Inc.20136—
+5K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+5K133061Espin SystemNlt Spine, Ltd.20130—
+5K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+5K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+5K121481Infini Radiofrequency SystemLutronic Corporation201357—
+5K122605PKS BillGyrus Acmi, Inc.20121—
+5K121264Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies201212—
+5K120095Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode…Depuy Mitek, A Johnson & Johnson Company20120—
+5K111520Ipc Powerease SystemMedtronic Xomed, Inc.20114182
+5K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+5K102366Finess EndoscopeEntellus Medical, Inc.20110—
+5K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+5K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+5K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+5K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+5K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+5K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+5K083352Veinwave, TC3000Newlands Clinical Trials, Ltd.20094—
+5K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+5K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics20081—
+5K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+5K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+5K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+5K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+5K072849Modification to Thermage Thermacool SystemThermage, Inc.200820—
+5K052936Thermage Thermacool SystemThermage, Inc.2007103—
+5K070004AccentAlma Lasers, Ltd.2007181—
+5K060948Portrait PSR3Rhytec Incorporated20061101
+5K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+5K051710Thermage Thermacool Coupling FluidThermage, Inc.200556—
+5K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+5K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+5K040135Thermage Thermacool SystemThermage, Inc.2004496—
+5K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+5K031489PitangaSyneron Medical, Ltd.20030—
+5K032088Modification to Thermacool TC SystemThermage, Inc.2003131—
+5K031988Aurora DSSyneron Medical, Ltd.2003450—
+5K031993Aurora SRSyneron Medical, Ltd.2003303—
+5K030426Omnilux RedPhoto Therapeutics Limited2003563—
+5K031046Thermacool TC SystemThermage, Inc.200322—
+5K024064Polaris DSSyneron Medical, Ltd.2003681—
+5K030142Thermacool TC SystemThermage, Inc.2003773—
+6K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+6K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…W&H Dentalwerk Buermoos GmbH20250—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc.202511
+6K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+6K240070Profound MatrixCandela Corporation20240—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K232684Surgify HaloSurgify Medical OY20233—
+6K231749Radio Frequency SystemShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+6K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+6K231126Eblator DeviceE Surgical, LLC20231—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+6K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+6K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+6K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+6K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH20221—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K210077MED RF 4000F Care Systems USA, LLC20211—
+6K211217Profound MatrixCandela Corporation20210—
+6K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+6K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+6K202120P300 AttachmentNakanishi, Inc.20211—
+6K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+6K210637CD Horizon™ Spinal SystemMedtronic202134—
+6K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd.20210—
+6K192621Medical RFTriworks Group Srl20200—
+6K202552Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss)20200—
+6K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+6K193201BTL-785FBtl20208—
+6K192033Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…Bennett Jacoby, Dds, Ms, Inc.20200—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+6K190281Ultrasonic Surgical SystemMedisonic Technology CO20190—