510(k) Report

Devices descending from K053560

23 later devices reach Modified Endosheath System for Vsi Flexible Cystoscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072180Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc.200720—
+1K071127Flexible Hysteroscope with Endosheath SystemVision-Sciences, Inc.20075—
+2K253905PrimeSight UltraView SystemCogentix Medical, Inc.20260—
+2K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc.20180—
+2K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc.20183—
+2K160766Ambu USR, Ambu MAmbu A/S201614—
+3K193095Ambu aScope 4 CystoAmbu A/S202013—
+3K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath RigidUvision360, Inc.20192—
+4K251140Zenflow Spring ScopeZenflow, Inc.20250—
+4K242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01…Hunan Vathin Medical Instrument Co., Ltd.20240—
+4K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20240—
+4K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)Lina Medical Aps20240—
+4K231118Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+4K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxMedimaging Integrated Solution, Inc (Miis)20230—
+4K221580Single-Use Flexible CystoscopeHunan Vathin Medical Instrument Co., Ltd.20220—
+4K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20221—
+4K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope…Zhuhai Pusen Medical Technology Co., Ltd.20221—
+4K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20221—
+4K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath…Uvision360, Inc.20191—
+5K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+5K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…MacroLux Medical Technology Co., Ltd.20240—
+5K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20230—
+5K210512LUMINELLE DTx SystemUvision360, Inc.20210—