510(k) Report

Devices descending from K971253

60 later devices reach Various Arthroscopes, Endoscopic Blades, Manual Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080560Henke Sass Wolf of America ArthroscopeHenke Sass Wolf of America, Inc.200821—
+1K043395Smith & Nephew VideoarthroscopeSmith & Nephew, Inc.200532—
+1K012652Reprocessed Dyonics Arthroscopic BursAlliance Medical Corp.200107
+1K012611Reprocessed Dyonics Arthroscopic ShaversAlliance Medical, Inc.200107
+1K982375Stryker Hip Arthoroscopy SetStryker Endoscopy19982—
+2K201349Smith+Nephew ArthroscopesSmith & Nephew20200—
+2K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC20186—
+2K122411J-Scope SystemMyelotec20130—
+2K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc.20117—
+2K093677Stryker ArthroscopeStryker Endoscopy201011—
+2K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc.201016—
+2K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC200821—
+2K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc.2008302
+2K072675Smith & Nephew ArthroscopeSmith & Nephew, Inc.20078—
+2K012635Reprocessed Stryker Arthroscopic ShaversAlliance Medical Corp.200108
+2K012605Reprocessed Athroscopics BursAlliance Medical Corp.200109
+3K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHand Biomechanics Lab, Inc.20250—
+3K223406SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments202321
+3K222490HBL Blade AssemblyHand Biomechanics Lab, Inc.20221—
+3K211297SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments20210—
+3K202659Stryker ArthroscopeStryker20201—
+3K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc.20180—
+3K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company20150—
+3K150776Medrobotics Flex SystemMedrobotics Corporation20151—
+3K143705NeedleCam HD Visualization SystemBiovision Technologies, LLC20152—
+3K141326Needle View CH Scope KitsBiovision Technologies, LLC20143—
+3K141119Camera Enabled ProbeTrice Medical, Inc.20147—
+3K140903Nuvis ArthroscopeIntegrated Endoscopy, Inc.20142—
+3K133941Mitek ArthroscopesMedos International SARL20140—
+3K122134Flexlite CameraSpine View, Inc.20120—
+3K123359OVS1 Video SystemOlive Medical Corp.20121—
+3K112548Altomec ArthroscopeAltomec Endoscopy, Inc.20120—
+3K100577Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20114—
+3K101734Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…Visionscope Technologies, LLC20107—
+4K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG20260—
+4K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC20260—
+4K252594UltraGuideCTR® image guided soft tissue release systemSonex Health20250—
+4K242417VECTR – Video Endoscopic Carpal Tunnel Release SystemRafael Medical Devices, LLC20240—
+4K203526C Scope Visualization SystemCit Ortho202102
+4K191594Nuvis Battery ArthroscopeIntegrated Endoscopy, Inc.20190—
+4K181982MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc.20182—
+4K170453Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+4K162475mi-eye 2, mi-eye 2 monitorTrice Medical20166—
+4K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/…Prosurg, Inc.20160—
+4K153606LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera…Smith & Nephew20166—
+4K1525138X-10-XXXX Camera SystemSanta Barbara Imaging Systems20150—
+4K110097Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20113—
+5K243020MIDASVuIntravu, Inc.20241—
+5K233115Hawkeye Control Unit with Eyas EndoscopeE Surgical, LLC20240—
+5K212556mi-eye 3 needlescope with cannula, mi-tablet 3Trice Medical, Inc.20210—
+5K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K…Smith and Nephew, Inc.20191—
+5K191345Pegasus SystemA.M. Surgical, Inc.20190—
+5K190367Smith & Nephew Tablet ApplicationSmith & Nephew20193—
+5K132433Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20141—
+6K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.20260—
+6K221740Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith &…Smith and Nephew, Inc.20220—
+6K192876INTELLIO Tablet ApplicationSmith & Nephew20202—
+6K153701ULYSS Multi View SinuscopeSopro-Comeg GmbH20160—
+7K203566Tablet ApplicationSmith & Nephew20211—
+8K221929Smith+Nephew INTELLIO TabletSmith+Nephew20220—