Single-Use Flexible Cystoscope
This Vathin flexible cystoscope provides endoscopic viewing and treatment access to the adult bladder. It works with a compatible Vathin digital video monitor, which processes and displays…
This Vathin flexible cystoscope provides endoscopic viewing and treatment access to the adult bladder. It works with a compatible Vathin digital video monitor, which processes and displays the endoscopic image, and with compatible endotherapy accessories.
The scope uses CMOS digital video and LED illumination. Its flexible insertion section bends up and down, while an instrument channel accommodates accessories and supports irrigation. The scope is supplied sterile for single use.
Channel and Scope Sizes
CY-E2E01 and E2E01R models have a 2.0 mm instrument channel; E2F01 and E2F01R have a 2.2 mm channel; E2G01 and E2G01R have a 2.4 mm channel. These configurations have a 400 mm working length, a 110-degree field of view, and 210-degree upward and downward bending.
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 | Hunan Vathin Medical Instrument Co., Ltd., China |
|---|---|
| FDA product code | FAJ |
| Device type | Cystoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K242535 |
| Record published | 2024-12-30 |
| Record revised | 2025-10-13 (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 |
| Packaging | Intermediate package of 2, shipping package of 10, intermediate package, pack of 10, 56972197480431 of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CY-E2G01R | In distribution | |
| CY-S1J00R | In distribution | |
| CY-S1B00 | In distribution | |
| CY-S1B00R | In distribution | |
| CY-E2G01 | In distribution | |
| CY-E2E01R | In distribution | |
| CY-S1E01 | In distribution | |
| CY-S1D00 | In distribution | |
| CY-E2F01R | In distribution | |
| CY-S2E01R | In distribution | |
| CY-S1J01R | In distribution | |
| CY-S1J01 | In distribution | |
| CY-S2E01 | In distribution | |
| CY-E2F01 | In distribution | |
| CY-S1E00R | In distribution | |
| CY-S1E00 | In distribution | |
| CY-S1H01 | In distribution | |
| CY-S1H01R | In distribution | |
| CY-S1D01R | In distribution | |
| CY-S1B01R | In distribution | |
| CY-S1H00R | In distribution | |
| CY-S1H00 | In distribution | |
| CY-S1B01 | In distribution | |
| CY-S1D00R | In distribution | |
| CY-E2E01 | In distribution | |
| CY-S1J00 | In distribution | |
| CY-S1D01 | In distribution | |
| CY-S1E01R | 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 |
|---|---|
| K242535 | 2024-12-18 |
| K221580 | 2022-11-18 |
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.