OES Elite
OES Elite is a reusable rigid cystoscope system for viewing and treating the lower urinary tract through the urethra. The assembled device combines a sheath, a blind or optical obturator,…
OES Elite is a reusable rigid cystoscope system for viewing and treating the lower urinary tract through the urethra. The assembled device combines a sheath, a blind or optical obturator, and a bridge. The filed two-way bridge is one component in the family.
Working channels allow compatible surgical instruments to be introduced during endoscopic procedures. The bridge designs include channels that accept instruments from above, while the sheath and obturator options determine other parts of the assembly.
Listed Item
Bridge, two-way, instrument channels from above, with stopcocks
Sheath Options and Reuse
Sheath tips include designs without a beak and designs with a beak and ramp. Most sheaths have a 212.9 mm working length, with one longer 284.5 mm model. The cystoscopes and accessories are supplied nonsterile and are reusable, with validated cleaning and steam-sterilization methods.
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 | Olympus Winter & IBE Gmbh, Germany |
|---|---|
| FDA product code | FAJ |
| Device type | Cystoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K260649 |
| Record published | 2026-06-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| WA2C17BO | In distribution | ||
| WA2S22BS | In distribution | ||
| WA2C2ANB | In distribution | ||
| WA2C25BO | In distribution | ||
| WA1SCM10 | 10 | In distribution | |
| WA2C19BS | In distribution | ||
| WA2C25BS | In distribution | ||
| WA1SCL10 | 10 | In distribution | |
| WA2C2BNB | In distribution | ||
| WA2C21LO | In distribution | ||
| WA2C21BO | In distribution | ||
| WA2S21LS | In distribution | ||
| WA2C19BV | In distribution | ||
| WA2C21RO | In distribution | ||
| WA2C0NNB | In distribution | ||
| WA2S25BS | In distribution | ||
| WA2C21SO | In distribution | ||
| WA2C2ASB | In distribution | ||
| WA2S19BS | In distribution | ||
| WA2C22BO | In distribution | ||
| WA2S17BS | In distribution | ||
| WA2S21BS | In distribution | ||
| WA2C21BS | In distribution | ||
| WA2S21RS | In distribution | ||
| WA2C1BSB | In distribution | ||
| WA2C2BSB | In distribution | ||
| WA2C22BV | In distribution | ||
| WA2C21LS | In distribution | ||
| WA2C25BV | In distribution | ||
| WA2C21BV | In distribution | ||
| WA2S21SS | In distribution | ||
| WA2C17BS | In distribution | ||
| WA2C21RS | In distribution | ||
| WA2CSR05 | 5 | In distribution | |
| WA2C19BO | In distribution | ||
| WA2C21SV | In distribution | ||
| WA2C21SS | In distribution | ||
| WA2C22BS | In distribution | ||
| WA2C1BNB | 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 |
| Cystoscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 39 |
| Accessory for urology | Sopro-Comeg GmbH | 34 |
| Cystoscope | Sopro-Comeg GmbH | 28 |
| Single-Use Flexible Cystoscope | Hunan Vathin Medical Instrument Co., Ltd. | 28 |
Showing 12 of 138. All products under Cystoscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260649 | 2026-05-21 |
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.