510(k) Report

Devices descending from K961971

339 later devices reach Q-5000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082813Stryker Led LightsourceStryker Corp.2008271
+1K973700Hermes Operating Room Control CenterComputer Motion, Inc.1998310—
+2K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation201591
+2K131226Novaprobe Led Light SourceNovaprobe Incorporated20140—
+2K130819CLL- V1 Light SourceOlympus Winter & Ibe GmbH20131—
+2K121724Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp.20121—
+2K101734Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…Visionscope Technologies, LLC20107—
+2K093792Led Light SourceSunoptic Technologies, LLC20106—
+2K031956Modification to Hermes O.R. Control CenterComputer Motion, Inc.20030—
+2K031720Modification to Hermes O.R. Control CenterComputer Motion, Inc.20030—
+2K031382Modification to Hermes O.R. Control CenterComputer Motion, Inc.20030—
+2K030240Modification to Hermes Operating Room Control CenterComputer Motion, Inc.20037—
+2K024294Modification to Hermes Operating Room Control CenterComputer Motion, Inc.20038—
+2K023095Hermes Operating Room Control CenterComputer Motion, Inc.20029—
+2K022897Modification to Hermes Operating Room Control CenterComputer Motion, Inc.20020—
+2K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments1999253—
+2K980787Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc.1998300—
+3K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.20260—
+3K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20250—
+3K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20232—
+3K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation20187—
+3K153606LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera…Smith & Nephew20166—
+3K141164Artemis Light EngineQuest Medical Imaging20150—
+3K123359OVS1 Video SystemOlive Medical Corp.20121—
+3K103813SOPRO 281Sopro20111—
+3K102167LO-50 Led Light SourceFiberoptics Technology, Inc.20103—
+3K060717Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20061—
+3K052740Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20052—
+3K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+3K040369Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments200478
+3K040300Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments200478
+3K032303Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments20041465
+3K032117Stryker Total Performance (TPS) SystemStryker Instruments2003238—
+3K031979Conmed Integrated Systems Nurses AssistantConmed Integrated Systems (Cmis)20030—
+3K020255Riwo Net Operating Operating Control System, Model #5590Richard Wolf Medical Instruments Corp.20021—
+3K014060Microaire 1000E SystemMicroaire Surgical Instruments, Inc.20027—
+3K991635Modification to Hermes Operating Room Control CenterComputer Motion, Inc.19990—
+3K990691Hermes Operating Room Control CenterComputer Motion, Inc.199942—
+4K252492Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20260—
+4K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™…CenterPoint Systems, LLC20240—
+4K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K…Smith and Nephew, Inc.20191—
+4K190367Smith & Nephew Tablet ApplicationSmith & Nephew20193—
+4K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation20195—
+4K161704Phasor DrillBiotex, Inc.201641
+4K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp.20160—
+4K1525138X-10-XXXX Camera SystemSanta Barbara Imaging Systems20150—
+4K132264PRIMADO2 Total Surgical SystemNakanishi, Inc.20136—
+4K092977Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme20101—
+4K091648Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis)20090—
+4K080444Conmed Linvatec Osprey Drill SystemConmed Linvatec20080—
+4K071859Stryker Crossfire SystemStryker Endoscopy200742
+4K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K050209Smith & Nephew Control Digital Operating Room SystemSmith & Nephew, Inc.20053—
+4K022942CraniocutAesculap, Inc.20020—
+4K991444Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready).Computer Motion, Inc.199940—
+4K991734Modification of: Hermes Operating Room Control CenterComputer Motion, Inc.19990—
+5K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…Scivita Medical Technology Co., Ltd.20260—
+5K252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC20250—
+5K252696LegacyPhasor Health, LLC20250—
+5K252060GREENPhasor Health, LLC20250—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K230619Hubly Electric Drill (H100)Hubly, Inc.20231—
+5K221740Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith &…Smith and Nephew, Inc.20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH20221—
+5K202120P300 AttachmentNakanishi, Inc.20211—
+5K193608EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG20210—
+5K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation20203—
+5K192876INTELLIO Tablet ApplicationSmith & Nephew20202—
+5K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+5K162770Relign SystemRelign Corporation20172—
+5K141975Waterlase Iplus SBiolase, Inc.20150—
+5K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K073411LiteduoLight Instruments20081—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K070556Brainsuite NetBrainlab AG20072—
+5K070388Profile Multi-Platform SystemSciton, Inc2007129—
+5K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+5K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+5K022393Merdoc SystemStryker Endoscopy200339—
+6K250815Hubly Drill (H100)Hubly, Inc.20250—
+6K252662UniBurNakanishi, Inc.20250—
+6K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.20240—
+6K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece…Relign Corporation, Subsidiary of Zimmer Biomet20240—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…Relign Corporation20231—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K203566Tablet ApplicationSmith & Nephew20211—
+6K193656SkyPulseFotona D.O.O.202011—
+6K173285Joule SystemSciton, Inc20185—
+6K161122Sony IP Converter NU-IP40SSony Electronics, Inc.20161—
+6K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+6K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+6K132976AdvatxAdvalight Aps20141—
+6K121893Stryker SDC3 HD Information Management SystemStryker Endoscopy201214—
+6K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—