510(k) Report

Devices descending from K912453

95 later devices reach Intelijet TM Fluid Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060123Levelert II Fluid Level SensorSmith & Nephew, Inc.20060—
+1K971253Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc.199760—
+1K962114Arthro-SurgimatW.O.M. World of Medicine GmbH199632—
+2K080560Henke Sass Wolf of America ArthroscopeHenke Sass Wolf of America, Inc.200821—
+2K043395Smith & Nephew VideoarthroscopeSmith & Nephew, Inc.200532—
+2K012652Reprocessed Dyonics Arthroscopic BursAlliance Medical Corp.200107
+2K012611Reprocessed Dyonics Arthroscopic ShaversAlliance Medical, Inc.200107
+2K983910Arthro-Surgimat-1500W.O.M. World of Medicine GmbH199831—
+2K982375Stryker Hip Arthoroscopy SetStryker Endoscopy19982—
+3K201349Smith+Nephew ArthroscopesSmith & Nephew20200—
+3K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC20186—
+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—
+3K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc.2008302
+3K072675Smith & Nephew ArthroscopeSmith & Nephew, Inc.20078—
+3K062380Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG2006151
+3K033927Arthoscopy Pump A115W.O.M. World of Medicine AG20043—
+3K012635Reprocessed Stryker Arthroscopic ShaversAlliance Medical Corp.200108
+3K012605Reprocessed Athroscopics BursAlliance Medical Corp.200109
+3K990443Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH199930—
+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—
+4K211297SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments20210—
+4K202659Stryker ArthroscopeStryker20201—
+4K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc.20180—
+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—
+4K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG201214—
+4K100577Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20114—
+4K101734Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…Visionscope Technologies, LLC20107—
+4K050580Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc.20052—
+4K030402Arthroscopy Pump, Model A107W.O.M. World of Medicine AG200329—
+5K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG20260—
+5K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC20260—
+5K252594UltraGuideCTR® image guided soft tissue release systemSonex Health20250—
+5K242417VECTR – Video Endoscopic Carpal Tunnel Release SystemRafael Medical Devices, LLC20240—
+5K203526C Scope Visualization SystemCit Ortho202102
+5K191594Nuvis Battery ArthroscopeIntegrated Endoscopy, Inc.20190—
+5K180735Endomat SelectKarl Storz SE & CO. KG20182—
+5K181982MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc.20182—
+5K180825Fluent Fluid Management SystemHologic, Inc.20182—
+5K173311ARTHRO-Pump PA304W.O.M. World of Medicine GmbH20180—
+5K173489GYN-Pump PH304W.O.M. World of Medicine GmbH201801
+5K172040Aquilex Fluid Control System AQL-100SW.O.M. World of Medicine GmbH201802
+5K170453Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+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—
+5K123732Hysteroscopy Pump HM6W.O.M. World of Medicine AG20136—
+5K123441Stryker Crossflow Arthroscopy PumpStryker Endoscopy20135—
+5K110097Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20113—
+5K063326Conmed Linvatec 24K Irrigation SystemConmed Linvatec20071—
+5K051326Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc.200516
+6K250795Purevue™ FMSW.O.M. World of Medicine GmbH20250—
+6K243020MIDASVuIntravu, Inc.20241—
+6K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…Hologic, Inc.20240—
+6K233115Hawkeye Control Unit with Eyas EndoscopeE Surgical, LLC20240—
+6K233710Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc.20240—
+6K212556mi-eye 3 needlescope with cannula, mi-tablet 3Trice Medical, Inc.20210—
+6K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG20201—
+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—
+6K191259Stryker CrossFlow Integrated Arthroscopy PumpStryker Corp.20190—
+6K190367Smith & Nephew Tablet ApplicationSmith & Nephew20193—
+6K190372Aveta SystemMeditrina, Inc.20194—
+6K182882CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote ControlConmed Corporation20180—
+6K171794Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc.20170—
+6K162770Relign SystemRelign Corporation20172—
+6K132433Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20141—
+7K261706Endomat Select (UP220)Karl Storz SE & CO. KG20260—
+7K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.20260—
+7K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece…Relign Corporation, Subsidiary of Zimmer Biomet20240—
+7K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…Relign Corporation20231—
+7K221740Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith &…Smith and Nephew, Inc.20220—
+7K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable…Meditrina, Inc.20221—
+7K192876INTELLIO Tablet ApplicationSmith & Nephew20202—
+7K192100Aveta Disposable HysteroscopeMeditrina, Inc.20190—
+7K191958Aveta SystemMeditrina, Inc.20190—
+7K153701ULYSS Multi View SinuscopeSopro-Comeg GmbH20160—
+8K223813Aveta System 2.0Meditrina, Inc.20230—
+8K203566Tablet ApplicationSmith & Nephew20211—
+9K221929Smith+Nephew INTELLIO TabletSmith+Nephew20220—