510(k) Report

Devices descending from K011849

26 later devices reach Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200369OES Elite Ureteroscopes and AccessoriesOlympus Winter & Ibe GmbH20200—
+1K052044Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6ALAcmi Corporation200525—
+2K072594Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc.200723—
+3K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc.200922—
+4K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI…Lina Medical Aps20184—
+4K123151Endosee Model 8000 U-ScopeEndosee Corp201320—
+4K093218Femeye TwoFem Suite, LLC20100—
+5K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording…Lina Medical Aps20200—
+5K181545Hysteroscope SystemShanghai AnQing Medical Instrument Co., Ltd.20192—
+5K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc.20175—
+5K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation201419—
+6K202445Hystero-V HysteroscopeHysterovue, Inc.20214—
+6K210270Medical Endoscope Image Processing SystemJiangsu Jiyuan Medical Technology Co., Ltd.20211—
+6K190797Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)Reed Medical (Zhejiang) Co., Ltd.20190—
+6K183020Endosee SystemCooperSurgical, Inc.201941
+6K151275MAKO DeviceNvision Medical20152—
+7K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope…Jiangsu Jiyuan Medical Technology Co., Ltd.20250—
+7K232003Endoscopic Video Image Processor, Single-Use Video HysteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.20243—
+7K190639Endosee SystemCooperSurgical, Inc.201931
+7K160510MAKO 7Nvision Medical Corporation20161—
+8K240978SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G…MacroLux Medical Technology Co., Ltd.20241—
+8K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+8K200038Endosee SystemCooperSurgical, Inc.20201—
+8K182975MAKO 7Boston Scientific Corporation20190—
+9K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A…Zhejiang Geyi Medical Instrument Co., Ltd.20260—
+9K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.20260—