510(k) Report

Devices descending from K914008

27 later devices reach Pentax Cystofiberscope, Model Fcy-15P through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040215Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath SystemVision-Sciences, Inc.200426—
+2K072180Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc.200720—
+2K071127Flexible Hysteroscope with Endosheath SystemVision-Sciences, Inc.20075—
+2K061663Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for…Rtc Inc.-Memcath Technologies, LLC20060—
+2K061324Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7Rtc Inc.-Memcath Technologies, LLC20060—
+2K053560Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc.200623—
+3K253905PrimeSight UltraView SystemCogentix Medical, Inc.20260—
+3K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc.20180—
+3K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc.20183—
+3K160766Ambu USR, Ambu MAmbu A/S201614—
+4K193095Ambu aScope 4 CystoAmbu A/S202013—
+4K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath RigidUvision360, Inc.20192—
+5K251140Zenflow Spring ScopeZenflow, Inc.20250—
+5K242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01…Hunan Vathin Medical Instrument Co., Ltd.20240—
+5K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20240—
+5K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)Lina Medical Aps20240—
+5K231118Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+5K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxMedimaging Integrated Solution, Inc (Miis)20230—
+5K221580Single-Use Flexible CystoscopeHunan Vathin Medical Instrument Co., Ltd.20220—
+5K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20221—
+5K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope…Zhuhai Pusen Medical Technology Co., Ltd.20221—
+5K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20221—
+5K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath…Uvision360, Inc.20191—
+6K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+6K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…MacroLux Medical Technology Co., Ltd.20240—
+6K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20230—
+6K210512LUMINELLE DTx SystemUvision360, Inc.20210—