510(k) Report

Devices descending from K082813

27 later devices reach Stryker Led Lightsource through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation201591
+1K131226Novaprobe Led Light SourceNovaprobe Incorporated20140—
+1K130819CLL- V1 Light SourceOlympus Winter & Ibe GmbH20131—
+1K121724Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp.20121—
+1K101734Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…Visionscope Technologies, LLC20107—
+1K093792Led Light SourceSunoptic Technologies, LLC20106—
+2K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.20260—
+2K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20250—
+2K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20232—
+2K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation20187—
+2K153606LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera…Smith & Nephew20166—
+2K141164Artemis Light EngineQuest Medical Imaging20150—
+2K123359OVS1 Video SystemOlive Medical Corp.20121—
+2K103813SOPRO 281Sopro20111—
+2K102167LO-50 Led Light SourceFiberoptics Technology, Inc.20103—
+3K252492Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20260—
+3K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™…CenterPoint Systems, LLC20240—
+3K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K…Smith and Nephew, Inc.20191—
+3K190367Smith & Nephew Tablet ApplicationSmith & Nephew20193—
+3K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation20195—
+3K1525138X-10-XXXX Camera SystemSanta Barbara Imaging Systems20150—
+4K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…Scivita Medical Technology Co., Ltd.20260—
+4K221740Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith &…Smith and Nephew, Inc.20220—
+4K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation20203—
+4K192876INTELLIO Tablet ApplicationSmith & Nephew20202—
+5K203566Tablet ApplicationSmith & Nephew20211—
+6K221929Smith+Nephew INTELLIO TabletSmith+Nephew20220—