510(k) Report

Devices descending from K771218

306 later devices reach Intra-Articular Shaver through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040369Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments200478
+1K040300Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments200478
+1K032303Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments20041465
+1K032117Stryker Total Performance (TPS) SystemStryker Instruments2003238—
+1K012652Reprocessed Dyonics Arthroscopic BursAlliance Medical Corp.200107
+1K012611Reprocessed Dyonics Arthroscopic ShaversAlliance Medical, Inc.200107
+1K971253Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc.199760—
+2K132264PRIMADO2 Total Surgical SystemNakanishi, Inc.20136—
+2K092977Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme20101—
+2K080560Henke Sass Wolf of America ArthroscopeHenke Sass Wolf of America, Inc.200821—
+2K071859Stryker Crossfire SystemStryker Endoscopy200742
+2K043395Smith & Nephew VideoarthroscopeSmith & Nephew, Inc.200532—
+2K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+2K982375Stryker Hip Arthoroscopy SetStryker Endoscopy19982—
+3K252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC20250—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH20221—
+3K202120P300 AttachmentNakanishi, Inc.20211—
+3K193608EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG20210—
+3K201349Smith+Nephew ArthroscopesSmith & Nephew20200—
+3K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC20186—
+3K162770Relign SystemRelign Corporation20172—
+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—
+3K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K012635Reprocessed Stryker Arthroscopic ShaversAlliance Medical Corp.200108
+3K012605Reprocessed Athroscopics BursAlliance Medical Corp.200109
+4K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHand Biomechanics Lab, Inc.20250—
+4K252662UniBurNakanishi, Inc.20250—
+4K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.20240—
+4K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece…Relign Corporation, Subsidiary of Zimmer Biomet20240—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…Relign Corporation20231—
+4K223406SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments202321
+4K222490HBL Blade AssemblyHand Biomechanics Lab, Inc.20221—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K211297SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments20210—
+4K202659Stryker ArthroscopeStryker20201—
+4K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc.20180—
+4K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+4K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company20150—
+4K150776Medrobotics Flex SystemMedrobotics Corporation20151—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+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—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K122134Flexlite CameraSpine View, Inc.20120—
+4K123359OVS1 Video SystemOlive Medical Corp.20121—
+4K112548Altomec ArthroscopeAltomec Endoscopy, Inc.20120—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K100577Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20114—
+4K101734Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…Visionscope Technologies, LLC20107—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K073411LiteduoLight Instruments20081—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+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—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K203526C Scope Visualization SystemCit Ortho202102
+5K193656SkyPulseFotona D.O.O.202011—
+5K191594Nuvis Battery ArthroscopeIntegrated Endoscopy, Inc.20190—
+5K181982MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc.20182—
+5K173285Joule SystemSciton, Inc20185—
+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—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110097Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20113—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—