Uro-V Cystoscope
The Uro-V cystoscope provides endoscopic views of the bladder and urethra and allows infusion of irrigating fluid. It is a portable battery operated instrument with a reusable handle and a…
The Uro-V cystoscope provides endoscopic views of the bladder and urethra and allows infusion of irrigating fluid. It is a portable battery operated instrument with a reusable handle and a sterile disposable cannula. The cannula carries a camera and LED illumination at its tip.
Images from the tip camera appear on the handle’s LCD screen. Handle buttons switch power, adjust illumination brightness and capture still images or start and stop video recording. A connector and locking mechanism secure the cannula to the handle, and its channel carries irrigation fluid.
Listed Item
The Uro-V cystoscope system consists of a multi-use handle with an LCD screen and a single-use cannula. The system is used for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.
Reuse and Supply
The handle contains the rechargeable battery and video processing electronics and is processed according to its instructions between uses. The cannula is supplied sterile for one patient and is discarded after the procedure.
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (3), Hunan (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Ningbo Wise Optomech Technology Corporation | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Zhejiang Tiansong Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 4 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
Showing 12 of 16. All 16 manufacturers in China registered for Cystoscope And Accessories, Flexible/Rigid
Record
| Listed by | Uroviu Corporation, United States |
|---|---|
| FDA product code | FAJ |
| Device type | Cystoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K171500 |
| Record published | 2022-12-16 |
| Record revised | 2023-11-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature -10 to 70 °C |
| Sizes | Catheter working length 254 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1012 | Catheter Working Length 254 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AED | National Advanced Endoscopy Devices, Inc. | 157 |
| Strauss Surgical | American Medical Endoscopy | 112 |
| Cystoscope And Accessories, Flexible/Rigid | Stryker GmbH | 61 |
| Hopkins | Karl Storz GmbH & Co. KG | 50 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 50 |
| Cystoscopy sheath | Sopro-Comeg GmbH | 42 |
| Cystoscopy instrument | Sopro-Comeg GmbH | 42 |
| Cystoscopy obturator | Sopro-Comeg GmbH | 41 |
| OES Elite | Olympus Winter & IBE Gmbh | 39 |
| Cystoscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 39 |
| Accessory for urology | Sopro-Comeg GmbH | 34 |
| Cystoscope | Sopro-Comeg GmbH | 28 |
Showing 12 of 138. All products under Cystoscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253226 | 2025-10-23 |
| K250797 | 2025-09-11 |
| K243196 | 2024-12-13 |
| K232837 | 2024-06-07 |
| K202921 | 2021-05-04 |
| K182876 | 2019-07-02 |
| K171500 | 2018-01-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.