Cystoscope and Accessories, Flexible/Rigid
[Dimpled Vaporizing Roller Ball Electrode, 24 Fr., Only for use with Stryker Resectoscopes 0502-880-401, 0502-880-402, Do not use if package is damaged]
16manufacturers in China registered for this device type
61catalogue numbers in this listing
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 | Stryker GmbH, Switzerland |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K233635 |
| Record published | 2016-09-23 |
| Record revised | 2023-09-04 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide, Moist Heat or Steam Sterilization, Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Pack of 6, pack of 3 |
| Sizes | Length 40 to 115 cm; outer diameter 2.9 to 4 mm |
| Distribution end date | 2023-09-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0504871040 | Length 40.0 cm | In distribution |
| 0502880206 | In distribution | |
| 0504843115 | Length 115.0 cm | In distribution |
| 0504880600 | In distribution | |
| 0504880312 | Degree: 90.0 Degree | In distribution |
| 0504881414 | Degree: 30.0 Degree | In distribution |
| 0502880211 | In distribution | |
| 0502555500 | Length 41.0 cm | In distribution |
| 0502740052 | Outer Diameter 4.0 mm | In distribution |
| 0502880302 | In distribution | |
| 0502881223 | In distribution | |
| 0502880523 | In distribution | |
| 0502240500 | Degree: 0.0 Degree | In distribution |
| 0504844115 | Length 115.0 cm | In distribution |
| 0504870040 | Length 40.0 cm | In distribution |
| 0502270100 | In distribution | |
| 0504861065 | Length 65.0 cm | In distribution |
| 0504880400 | Degree: 30.0 Degree | In distribution |
| 0504841115 | Length 115.0 cm | In distribution |
| 0504880314 | Degree: 90.0 Degree | In distribution |
| 0502880427 | In distribution | |
| 0502880429 | In distribution | |
| 0504880800 | In distribution | |
| 0504881312 | Degree: 90.0 Degree | In distribution |
| 0502881219 | In distribution | |
| 0502880202 | In distribution | |
| 0502729060 | In distribution | |
| 0502880205 | In distribution | |
| 0504880414 | Degree: 30.0 Degree | In distribution |
| 0504881314 | Degree: 90.0 Degree | In distribution |
| 0504860065 | Length 65.0 cm | In distribution |
| 0504880200 | In distribution | |
| 0502270500 | Degree: 0.0 Degree | In distribution |
| 0502023029 | Outer Diameter 2.9 mm | In distribution |
| 0502880226 | In distribution | |
| 0502270530 | Degree: 30.0 Degree | In distribution |
| 0502977030 | In distribution | |
| 0502880209 | In distribution | |
| 0502880650 | In distribution | |
| 0502720000 | In distribution | |
| 0504862065 | Length 65.0 cm | In distribution |
| 0502881217 | In distribution | |
| 0502880303 | In distribution | |
| 0502880603 | In distribution | |
| 0504881412 | Degree: 30.0 Degree | In distribution |
| 0502220200 | In distribution | |
| 0502880327 | In distribution | |
| 0502555100 | Length 41.0 cm | In distribution |
| 0502880218 | In distribution | |
| 0502880402 | In distribution | |
| 0505880205 | Length 60.0 cm | In distribution |
| 0504880500 | Degree: 0.0 Degree | In distribution |
| 0502740062 | Outer Diameter 4.0 mm | In distribution |
| 0502880203 | In distribution | |
| 0502240590 | Degree: 90.0 Degree | Withdrawn |
| 0504872040 | Length 40.0 cm | Withdrawn |
| 0504842115 | Length 115.0 cm | Withdrawn |
| 0504881100 | Withdrawn | |
| 0504833090 | Length 90.0 cm | Withdrawn |
| 0502240200 | Withdrawn | |
| 0504880100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AED | National Advanced Endoscopy Devices, Inc. | 157 |
| Strauss Surgical | American Medical Endoscopy | 112 |
| 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 |
| Single-Use Flexible Cystoscope | Hunan Vathin Medical Instrument Co., Ltd. | 28 |
Showing 12 of 138. All products under Cystoscope And Accessories, Flexible/Rigid
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.