Uro-G Flexible Cystoscope
The Uro-G Flexible Cystoscope provides endoscopic views of the bladder and urethra and permits infusion of irrigating fluid. It combines a sterile, disposable steerable cannula with a…
The Uro-G Flexible Cystoscope provides endoscopic views of the bladder and urethra and permits infusion of irrigating fluid. It combines a sterile, disposable steerable cannula with a reusable, battery-powered handle containing a video display.
A CMOS camera and LED at the cannula tip provide the image and illumination. The cannula connects and locks to the handle, whose electronics process the video and display it on an LCD screen. A channel within the cannula delivers irrigating fluid.
Listed Item
The Uro-G Flexible Cystoscope System consists of a multi-use handle with an LCD screen and a single-use sterile cannula. The Uro-G Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.
Handle Controls
Buttons on the handle control power, adjust illumination and capture still images or start and stop video recording. The handle contains a rechargeable battery and is detached from the single-use cannula after use.
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) | K202921 |
| Record published | 2022-12-16 |
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 | Storage environment temperature -10 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1520 | 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.