FDA.reportPublic FDA data

Flexible video cystoscope, single-use

Definition
A sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a single-use device.
GUDID devices
202
Last updated
2026-09-14 22:39:42

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06975339621506BubbleViewMacroLux Medical Technology Co., Ltd.C38-CS2026-08-14
06975339621513BubbleViewMacroLux Medical Technology Co., Ltd.C38-CRS2026-08-14
06975339621520BubbleViewMacroLux Medical Technology Co., Ltd.C50-CB2026-08-14
06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.C50-CBR2026-08-14
06975339621926BubbleViewMacroLux Medical Technology Co., Ltd.C38-CS2026-08-14
06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.C38-CRS2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.C50-CB2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.C50-CBR2026-08-14
04719872715146VersaVue™MEDIMAGING INTEGRATED SOLUTION INC.50082023-10-20
06975339621179BubbleView®MacroLux Medical Technology Co., Ltd.C50-C2024-07-10
06975339621186BubbleView®MacroLux Medical Technology Co., Ltd.C50-CR2024-07-10
06975339621940BubbleView®MacroLux Medical Technology Co., Ltd.C50-C2025-09-05
06975339621957BubbleViewMacroLux Medical Technology Co., Ltd.C50-CR2025-09-05
00850023925442WiScope®Otu Medical Inc.OTU-C380SL (OTU-300S)2026-07-28
00850023925459WiScope®Otu Medical Inc.OTU-C380RL (OTU-C300R)2026-07-28
00850023925466WiScope®Otu Medical Inc.OTU-C380SR (OTU-C310S)2026-07-28
00850023925473WiScope®Otu Medical Inc.OTU-C380RR (OTU-C310R)2026-07-28
00850023925565WiScope®Otu Medical Inc.OTU-C320S2026-07-28
00850023925572WiScope®Otu Medical Inc.OTU-C320R2026-07-28
00850023925589WiScope®Otu Medical Inc.OTU-C330S2026-07-28
00850023925596WiScope®Otu Medical Inc.OTU-C330R2026-07-28
00850023925909WiScope®Otu Medical Inc.OTU-CK320S2026-07-28
00850023925916WiScope®Otu Medical Inc.OTU-CK320R2026-07-28
00850023925923WiScope®Otu Medical Inc.OTU-CK330S2026-07-28
00850023925930WiScope®Otu Medical Inc.OTU-CK330R2026-07-28
00850023925985WiScope®Otu Medical Inc.OTU-CK320SU2026-07-28
00850023925992WiScope®Otu Medical Inc.OTU-CK320RU2026-07-28
06972084140498WiScope®Ningbo Wise Optomech Technology CorporationOTU-C380RL2026-07-28
06972084140504WiScope®Ningbo Wise Optomech Technology CorporationOTU-C380RR2026-07-28
06972084140511WiScope®Ningbo Wise Optomech Technology CorporationOTU-C380SL2026-07-28
06972084140528WiScope®Ningbo Wise Optomech Technology CorporationOTU-C380SR2026-07-28
06972084140597WiScope®Ningbo Wise Optomech Technology CorporationOTU-C311S2026-07-28
06972084140603WiScope®Ningbo Wise Optomech Technology CorporationOTU-C311R2026-07-28
06972084140610AptraNingbo Wise Optomech Technology CorporationBDACYSD012026-07-28
06972084140627AptraNingbo Wise Optomech Technology CorporationBDACYRD012026-07-28
06972084140665WiScope®Ningbo Wise Optomech Technology CorporationOTU-C320S2026-07-28
06972084140672WiScope®Ningbo Wise Optomech Technology CorporationOTU-C320R2026-07-28
06972084140689WiScope®Ningbo Wise Optomech Technology CorporationOTU-C330S2026-07-28
06972084140696WiScope®Ningbo Wise Optomech Technology CorporationOTU-C330R2026-07-28
06973786290580Flexible Video-Choledo-Cysto-UreteroscopeShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)UV-100-E2023-07-26
06973786290597Flexible Video-Choledo-Cysto-UreteroscopeShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)UV-110-E2023-07-26
06973786290603Flexible Video-Choledo-Cysto-UreteroscopeShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)UV-100T-E2023-07-26
06973786290610Flexible Video-Choledo-Cysto-UreteroscopeShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)UV-110T-E2023-07-26
00840432200001CFlex™Verathon Medical (Canada) ULCSingle-Use Cystoscope, Standard Deflection2026-05-15
00840432200018CFlex™Verathon Medical (Canada) ULCSingle-Use Cystoscope, Reverse Deflection2026-05-15
00850023925169WiScope®Otu Medical Inc.OTU-C300S2022-04-18
00850023925176WiScope®Otu Medical Inc.OTU-C300R2022-04-18
00850023925183WiScope®Otu Medical Inc.OTU-C310S2022-04-18
00850023925190WiScope®Otu Medical Inc.OTU-C310R2022-04-18
00850023925381AptraOtu Medical Inc.BDCYSD012024-09-30
00850023925398AptraOtu Medical Inc.BDCYRD012024-09-30
00850023925428WiScope®Otu Medical Inc.OTU-C311S2024-09-30
00850023925435WiScope®Otu Medical Inc.OTU-C311R2024-09-30
00851545007555ProsurgPROSURG INCNFU9 EU2020-05-21
00851545007586ProsurgPROSURG INCNCO2020-04-30
00851545007593ProsurgPROSURG INCNCO182020-04-30
00851545007609ProsurgPROSURG INCNCD2020-04-30
00851545007616ProsurgPROSURG INCNFC122020-04-30
00851545007630ProsurgPROSURG INCNSU92020-04-30
00851545007647ProsurgPROSURG INCNNC92020-04-30
00851545007654ProsurgPROSURG INCNNC122020-04-30
00851545007661ProsurgPROSURG INCNNC152020-04-30
00851545007678ProsurgPROSURG INCNNC202020-04-30
00851545007685ProsurgPROSURG INCVPU52020-04-30
00851545007692ProsurgPROSURG INCNVL2020-04-30
00851545007739ProsurgPROSURG INCNFC152020-04-30
00851545007807ProsurgPROSURG INCNFC92020-05-12
00851545007838ProsurgPROSURG INCHFH122020-05-21
00851545007845ProsurgPROSURG INCNFH92020-05-21
00860008483706Uro-G Flexible CystoscopeUROVIU CORP.15202022-12-16
00888937022469Endosee Cystoscopy CannulaCoopersurgical, Inc.OR-ESCX52018-11-09
04719872715153 VersaVue™MEDIMAGING INTEGRATED SOLUTION INC.50082023-10-20
04719872715177 VersaVue™MEDIMAGING INTEGRATED SOLUTION INC.50082023-10-20
04719872715191 VersaVue™MEDIMAGING INTEGRATED SOLUTION INC.50082023-10-20
05707480136063Isiris™ aAmbu A/SALFA012018-07-30
05707480140558aScope™ 4 CystoAmbu A/S6000010002021-02-04
05707480140589aScope™ 4 CystoAmbu A/S6010010002020-05-20
05707480146314aScope™ 4 CystoAmbu A/S6000050002021-08-02
05707480146345aScope™ 4 CystoAmbu A/S6010050002021-05-17
05707480157679aScope™ 4 CystoAmbu A/S6001010002023-03-08