510(k) Report

Devices descending from K953695

107 later devices reach Dyonics Disposable Arthroscopic Blades through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130912Omnicut Resection BladeDepuy Mitek, A Johnson & Johnson Company20130—
+1K060172Rema Shaver BladesRema Medizintechnik GmbH.20060—
+1K052695Suretek Medical Reprocessed Arthroscopic Blades and BursSuretek Medical20060—
+1K031787Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc.2003371
+1K023777Arthronet Blackline 2 and 3 Piece Arthroscopic Blades, Models 123, 133, 153, 163, 173…Arthronet Medical, Inc.20021—
+1K022744Reprocessed Used Disposable Arthroscopic Blades and BursMedical Device Services20020—
+1K012694Reprocessed Used Disposable Arthroscopic Blades and BursAdven Medical20020—
+1K012652Reprocessed Dyonics Arthroscopic BursAlliance Medical Corp.200107
+1K012611Reprocessed Dyonics Arthroscopic ShaversAlliance Medical, Inc.200107
+1K012536Reprocessed Powered Arthroscopic AccessoriesSterilmed, Inc.20011—
+1K971253Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc.199760—
+2K132015Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc.2013241
+2K113028Medisiss Reprocessed Arthroscopic Shavers and BursMedisiss20110—
+2K110038Truclear Morcellator SystemSmith & Nephew, Inc.201125—
+2K103389Truclear Incisor Plus Blade 2.9Smith & Nephew, Inc.201125—
+2K080560Henke Sass Wolf of America ArthroscopeHenke Sass Wolf of America, Inc.200821—
+2K043395Smith & Nephew VideoarthroscopeSmith & Nephew, Inc.200532—
+2K041774Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc.200434—
+2K982375Stryker Hip Arthoroscopy SetStryker Endoscopy19982—
+3K223520UNIDRIVE SIII SystemKarl Storz-Endoscopy-America, Inc.20232—
+3K201349Smith+Nephew ArthroscopesSmith & Nephew20200—
+3K190372Aveta SystemMeditrina, Inc.20194—
+3K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC20186—
+3K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal DeviceSmith & Nephew, Inc.20160—
+3K142029Myosure Hysteroscopic Tissue Removal SystemHologic, Inc.201414—
+3K122411J-Scope SystemMyelotec20130—
+3K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc.20117—
+3K093677Stryker ArthroscopeStryker Endoscopy201011—
+3K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc.201016—
+3K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC200821—
+3K073690Interlace Medical Hysteroscopic Morcellation SystemInterlace Medical, Inc.20088—
+3K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc.2008302
+3K072675Smith & Nephew ArthroscopeSmith & Nephew, Inc.20078—
+3K012635Reprocessed Stryker Arthroscopic ShaversAlliance Medical Corp.200108
+3K012605Reprocessed Athroscopics BursAlliance Medical Corp.200109
+4K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD)…Karl Storz SE & CO. KG20260—
+4K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG20260—
+4K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHand Biomechanics Lab, Inc.20250—
+4K223406SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments202321
+4K222490HBL Blade AssemblyHand Biomechanics Lab, Inc.20221—
+4K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable…Meditrina, Inc.20221—
+4K211297SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments20210—
+4K202659Stryker ArthroscopeStryker20201—
+4K192100Aveta Disposable HysteroscopeMeditrina, Inc.20190—
+4K191958Aveta SystemMeditrina, Inc.20190—
+4K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc.20180—
+4K173901MyoSure MANUAL Tissue Removal DeviceHologic, Inc.20184—
+4K170120EndoRotorInterscope, Inc.20171—
+4K152723Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc.20156—
+4K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company20150—
+4K150776Medrobotics Flex SystemMedrobotics Corporation20151—
+4K143705NeedleCam HD Visualization SystemBiovision Technologies, LLC20152—
+4K141326Needle View CH Scope KitsBiovision Technologies, LLC20143—
+4K141119Camera Enabled ProbeTrice Medical, Inc.20147—
+4K140903Nuvis ArthroscopeIntegrated Endoscopy, Inc.20142—
+4K133941Mitek ArthroscopesMedos International SARL20140—
+4K122134Flexlite CameraSpine View, Inc.20120—
+4K123359OVS1 Video SystemOlive Medical Corp.20121—
+4K112548Altomec ArthroscopeAltomec Endoscopy, Inc.20120—
+4K100577Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20114—
+4K101734Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…Visionscope Technologies, LLC20107—
+4K091100Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc.20097—
+5K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG20260—
+5K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC20260—
+5K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.20260—
+5K252594UltraGuideCTR® image guided soft tissue release systemSonex Health20250—
+5K242417VECTR – Video Endoscopic Carpal Tunnel Release SystemRafael Medical Devices, LLC20240—
+5K223813Aveta System 2.0Meditrina, Inc.20230—
+5K203526C Scope Visualization SystemCit Ortho202102
+5K201756Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal…Stryker Sustainability Solutions20200—
+5K191538Resectr Tissue Resection DeviceBoston Scientific Corporation20201—
+5K191594Nuvis Battery ArthroscopeIntegrated Endoscopy, Inc.20190—
+5K182675Polygon Resection DevicePolygon Medical, Inc.20190—
+5K181127EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set…Interscope, Inc.20190—
+5K181982MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc.20182—
+5K170453Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+5K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc.20175—
+5K162475mi-eye 2, mi-eye 2 monitorTrice Medical20166—
+5K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/…Prosurg, Inc.20160—
+5K153606LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera…Smith & Nephew20166—
+5K1525138X-10-XXXX Camera SystemSanta Barbara Imaging Systems20150—
+5K110097Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20113—
+5K103741Surgisure Tissue Removal SystemInterlace Medical, Inc.20110—
+5K100559Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc.20106—
+6K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.20260—
+6K243020MIDASVuIntravu, Inc.20241—
+6K233115Hawkeye Control Unit with Eyas EndoscopeE Surgical, LLC20240—
+6K212556mi-eye 3 needlescope with cannula, mi-tablet 3Trice Medical, Inc.20210—
+6K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K…Smith and Nephew, Inc.20191—
+6K191345Pegasus SystemA.M. Surgical, Inc.20190—
+6K190367Smith & Nephew Tablet ApplicationSmith & Nephew20193—
+6K181974MyoSure XL Tissue Removal Device for FluentHologic, Inc.20181—
+6K180825Fluent Fluid Management SystemHologic, Inc.20182—
+6K132433Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20141—
+6K131581Myosure Tissue Removal Device (1 Pack and 3 Pack)Hologic, Inc.20130—
+6K122498Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3 Pack)Hologic, Inc.20121—
+6K121868Myosure Lite Tissue Removal Device (1 Pack), Myosure Lite Tissue Removal Device (3 Pack)Hologic, Inc.20120—
+6K120593Myosure Control UnitHologic, Inc.20120—
+7K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.20260—
+7K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…Hologic, Inc.20240—