FDA.reportPublic FDA data

Flexible video ureteroscope, single-use

Definition
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are typically transmitted by a video system with a high definition complementary metal oxide semiconductor (CMOS) chip at the distal end with images showing on a monitor. This device is commonly used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a single-use device.
GUDID devices
223
Last updated
2026-08-08 10:08:51

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850023925602WiScope®Otu Medical Inc.OTU-140R2026-07-28
00850023925619WiScope®Otu Medical Inc.OTU-140S2026-07-28
00850023925626WiScope®Otu Medical Inc.OTU-110R2026-07-28
00850023925633WiScope®Otu Medical Inc.OTU-110S2026-07-28
00850023925640WiScope®Otu Medical Inc.OTU-130R2026-07-28
00850023925657WiScope®Otu Medical Inc.OTU-130S2026-07-28
00850023925978AptraOtu Medical Inc.BDRD022026-07-28
06972084140429AptraNingbo Wise Optomech Technology CorporationBDASD012026-07-28
06972084140436AptraNingbo Wise Optomech Technology CorporationBDARD012026-07-28
06972084140450WiScope®Ningbo Wise Optomech Technology CorporationOTU-100RL2026-07-28
06972084140467WiScope®Ningbo Wise Optomech Technology CorporationOTU-100RR2026-07-28
06972084140474WiScope®Ningbo Wise Optomech Technology CorporationOTU-100SL2026-07-28
06972084140481WiScope®Ningbo Wise Optomech Technology CorporationOTU-100SR2026-07-28
06972084140559WiScope®Ningbo Wise Optomech Technology CorporationOTU-OM100S2026-07-28
06972084140566WiScope®Ningbo Wise Optomech Technology CorporationOTU-OM100R2026-07-28
06972084140573WiScope®Ningbo Wise Optomech Technology CorporationOTU-120R2026-07-28
06972084140580WiScope®Ningbo Wise Optomech Technology CorporationOTU-120S2026-07-28
06972084140702WiScope®Ningbo Wise Optomech Technology CorporationOTU-140R2026-07-28
06972084140719WiScope®Ningbo Wise Optomech Technology CorporationOTU-140S2026-07-28
06972084140757WiScope®Ningbo Wise Optomech Technology CorporationOTU-110R2026-07-28
06972084140764WiScope®Ningbo Wise Optomech Technology CorporationOTU-110S2026-07-28
06972084140771WiScope®Ningbo Wise Optomech Technology CorporationOTU-130R2026-07-28
06972084140788WiScope®Ningbo Wise Optomech Technology CorporationOTU-130S2026-07-28
06972084140795AptraNingbo Wise Optomech Technology CorporationBDASD022026-07-28
06972084140801AptraNingbo Wise Optomech Technology CorporationBDARD022026-07-28
06971381254228Single-use Flexible UreteroscopeScivita Medical Technology Co., Ltd.SUV-2C-B2026-07-16
06973786290627Flexible Video-Choledo-Cysto-UreteroscopeShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)UV-US100-H(REV)2023-07-26
06973786290634Flexible Video-Choledo-Cysto-UreteroscopeShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)UV-US110-H(REV)2023-07-26
06973786291396Flexible Video-Choledo-Cysto-UreteroscopeShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)UV-US100-H(STD)2024-09-14
06973786291402Flexible Video-Choledo-Cysto-UreteroscopeShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)UV-US110-H(STD)2024-09-14
00724995209162Uretero1BLACK DIAMOND VIDEO, INC.UROSD1012022-06-10
00724995209179Uretero1BLACK DIAMOND VIDEO, INC.URORD1012022-06-10
00810116023387Dornier Axis IIDORNIER MEDTECH AMERICA, INC.Dornier AXIS II E URS FLEX EU - Ureteroscope2026-05-06
00810116023400Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier AXIS II D URS FLEX EU - Ureteroscope2026-05-06
00810116023424Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier AXIS II CYSTO FLEX EU - Ureteroscope2026-05-06
00810116023578Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier AXIS II Slim URS FLEX EU - Ureteroscope2026-05-06
00810116024056Dornier MedTech DORNIER MEDTECH AMERICA, INC.AXIS II Clerix Suction URS Reverse Deflection2026-03-26
00810116024070Dornier MedTech DORNIER MEDTECH AMERICA, INC.AXIS II Clerix Suction URS2026-03-26
00810116024094Dornier MedTech DORNIER MEDTECH AMERICA, INC.AXIS II Clerix Suction URS2026-03-26
00810116024117Dornier MedTech DORNIER MEDTECH AMERICA, INC.AXIS II Clerix Suction URS2026-03-26
00850023925022AptraOtu Medical Inc.BDSD012021-11-24
00850023925039AptraOtu Medical Inc.BDRD012021-11-29
00850023925046WiScope®Otu Medical Inc.OTU-100RL2021-04-17
00850023925053WiScope®Otu Medical Inc.OTU-100RR2021-04-17
00850023925060WiScope®Otu Medical Inc.OTU-100SL2021-04-17
00850023925077WiScope®Otu Medical Inc.OTU-100SR2021-04-17
00850023925121WiScope®Otu Medical Inc.OTU-C380RL2021-04-17
00850023925152WiScope®Otu Medical Inc.OTU-C380SR2021-04-17
00850023925305WiScope®Otu Medical Inc.OTU-OM100R2023-04-30
00850023925329WiScope®Otu Medical Inc.OTU-120R2024-01-12
00850023925336WiScope®Otu Medical Inc.OTU-120S2024-01-12
00860005357710CVAC Aspiration SystemCalyxo, Inc.CVC127020-12024-02-22
00860005357741CVAC Aspiration SystemCalyxo, Inc.CVC127020R-12025-09-10
06971176280012UscopeZhuhai Pusen Medical Technology Co, LtdPU30222017-09-12
06971176280029UscopeZhuhai Pusen Medical Technology Co, LtdPU3022A2017-09-12
06971176280418UscopeZhuhai Pusen Medical Technology Co, LtdPU3022A2022-12-05
06971176280425UscopeZhuhai Pusen Medical Technology Co, LtdPU30222022-12-05
06971176280432UscopeZhuhai Pusen Medical Technology Co, LtdPU3033A2022-12-05
06971176281248UscopeZhuhai Pusen Medical Technology Co, LtdPU3033AH (Reverse Deflection)2024-07-30
06971176281255UscopeZhuhai Pusen Medical Technology Co, LtdPU3033AH (Standard Deflection)2024-07-30
06971176281262UscopeZhuhai Pusen Medical Technology Co, LtdPU3033H (Reverse Deflection)2024-07-30
06971176281279UscopeZhuhai Pusen Medical Technology Co, LtdPU3033H (Standard Deflection)2024-07-30
06971176281286UscopeZhuhai Pusen Medical Technology Co, LtdPU400A (Reverse Deflection)2024-07-30
06971176281293UscopeZhuhai Pusen Medical Technology Co, LtdPU400A (Standard Deflection)2024-07-30
06971176281309UscopeZhuhai Pusen Medical Technology Co, LtdPU411A (Reverse Deflection)2024-07-30
06971176281316UscopeZhuhai Pusen Medical Technology Co, LtdPU411A (Standard Deflection)2024-07-30
06971176281408UscopeZhuhai Pusen Medical Technology Co, LtdPU3033A-S2024-10-31
06971176281415UscopeZhuhai Pusen Medical Technology Co, LtdPU3033A-R2024-10-31
06971176281422UscopeZhuhai Pusen Medical Technology Co, LtdPU3033AH-S2024-10-31
06971176281439UscopeZhuhai Pusen Medical Technology Co, LtdPU3033AH-R2024-10-31
06971176281446UscopeZhuhai Pusen Medical Technology Co, LtdPU400A-S2024-10-31
06971176281453UscopeZhuhai Pusen Medical Technology Co, LtdPU400A-R2024-10-31
06971176281460UscopeZhuhai Pusen Medical Technology Co, LtdPU411A-S2024-10-31
06971176281477UscopeZhuhai Pusen Medical Technology Co, LtdPU411A-R2024-10-31
06971176281828Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdPU3033AH-S2025-10-17
06971176281835Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdPU3033AH-R2025-10-17
06971176281842Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdPU3033H-R2025-10-17
06971176281859Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdPU3033H-S2025-10-17
06971176281866Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdPU400A-S2025-10-17
06971176281873Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdPU400A-R2025-10-17