510(k) Report

Devices descending from K052044

25 later devices reach Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6AL through their predicates, nearest generation first.

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