510(k) Report

Devices descending from K193095

13 later devices reach Ambu aScope 4 Cysto through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251140Zenflow Spring ScopeZenflow, Inc.20250—
+1K242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01…Hunan Vathin Medical Instrument Co., Ltd.20240—
+1K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20240—
+1K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)Lina Medical Aps20240—
+1K231118Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+1K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxMedimaging Integrated Solution, Inc (Miis)20230—
+1K221580Single-Use Flexible CystoscopeHunan Vathin Medical Instrument Co., Ltd.20220—
+1K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20221—
+1K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope…Zhuhai Pusen Medical Technology Co., Ltd.20221—
+1K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20221—
+2K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+2K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…MacroLux Medical Technology Co., Ltd.20240—
+2K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20230—