510(k) Report

Devices descending from K133538

25 later devices reach Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241500Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible…Guangzhou Red Pine Medical Instrument Co., Ltd.20242—
+1K221683CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R)…Olympus Medical Systems Corporation202315
+1K221690Oes Cystonephro Fiberscope (Olympus Cyf-5), Oes Cystonephro Fiberscope (Olympus Cyf-5R)…Olympus Medical Systems Corp.202203
+1K182723Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.20193—
+1K160766Ambu USR, Ambu MAmbu A/S201614—
+2K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)Guangzhou Red Pine Medical Instrument Co., Ltd.20250—
+2K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20250—
+2K243321Endoscopic Video Image Processor (RP-IPD-V1000F)Guangzhou Red Pine Medical Instrument Co., Ltd.20250—
+2K193095Ambu aScope 4 CystoAmbu A/S202013—
+2K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.20192—
+3K251140Zenflow Spring ScopeZenflow, Inc.20250—
+3K242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01…Hunan Vathin Medical Instrument Co., Ltd.20240—
+3K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20240—
+3K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)Lina Medical Aps20240—
+3K231118Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+3K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxMedimaging Integrated Solution, Inc (Miis)20230—
+3K221580Single-Use Flexible CystoscopeHunan Vathin Medical Instrument Co., Ltd.20220—
+3K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20221—
+3K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope…Zhuhai Pusen Medical Technology Co., Ltd.20221—
+3K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20221—
+3K212476KARL STORZ Flexible HD Cysto-Urethroscope SystemKarl Storz Endoscopy America, Inc.202101
+3K202957Flexible Video Cysto-Urethroscope (C-view)KARL STORZ Endoscopy-America, Inc.202012
+4K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+4K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…MacroLux Medical Technology Co., Ltd.20240—
+4K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20230—