Strauss Surgical
112 catalogue numbers from STS-URO-045-02, listed by American Medical Endoscopy, United States, under Cystoscope And Accessories, Flexible/Rigid. 16 manufacturers in China are registered for this product code.
16manufacturers in China registered for this device type
112catalogue numbers in this listing
2510(k) clearances naming this product code
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 | American Medical Endoscopy, 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, Repacker / relabeller, Manufacturer |
| 510(k) | K260271 |
| Record published | 2024-04-15 |
| Record revised | 2023-11-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STS-URO-045-02 | In distribution | |
| STS-HYS-340-03-BP | In distribution | |
| STS-URO-230-24-BP-SL | In distribution | |
| STS-HYS-335-60U | In distribution | |
| STS-HYS-046-08 | In distribution | |
| STS-URO-BIO-43-OPT | In distribution | |
| STS-URO-100-127-QL-BP | In distribution | |
| STS-HYS-175-23-BP | In distribution | |
| STS-HYS-340-02 | In distribution | |
| STS-URO-320-10 | In distribution | |
| STS-URO-020-16 | In distribution | |
| STS-9029-302BA | In distribution | |
| STS-URO-100-122-QL | In distribution | |
| STS-HYS-175-18-SET | In distribution | |
| STS-URO-320-10-TL | In distribution | |
| STS-URO-020-21 | In distribution | |
| STS-HYS-310-21 | In distribution | |
| STS-URO-2430-209-SL-KK | In distribution | |
| STS-9029-302AA | In distribution | |
| STS-URO-045-40 | In distribution | |
| STS-HYS-325-19 | In distribution | |
| STS-HYS-175-24-BP | In distribution | |
| STS-URO-215-24-BP | In distribution | |
| STS-9040-302BA | In distribution | |
| STS-URO-340-20-TL-SET | In distribution | |
| STS-HYS-335-60-BP | In distribution | |
| STS-2040-283BA-OLY | In distribution | |
| STS-2029-302BA | In distribution | |
| STS-URO-020-25 | In distribution | |
| STS-URO-GRA-43-OPT | In distribution | |
| STS-URO-030-01 | In distribution | |
| STS-HF-533-04 | In distribution | |
| STS-URO-240-25 | In distribution | |
| STS-URO-047-08 | In distribution | |
| STS-URO-001-21-SET | In distribution | |
| STS-URO-235-60-BP-SL | In distribution | |
| STS-URO-001-23-SET | In distribution | |
| STS-URO-001-16 | In distribution | |
| STS-URO-045-23 | In distribution | |
| STS-9040-302AA | In distribution | |
| STS-2029-302AA | In distribution | |
| STS-URO-035-01 | In distribution | |
| STS-URO-400-00 | In distribution | |
| STS-URO-100-200 | In distribution | |
| STS-URO-020-23 | In distribution | |
| STS-2040-302BSA | In distribution | |
| STS-HYS-315-19 | In distribution | |
| STS-URO-001-25 | In distribution | |
| STS-URO-235-24 | In distribution | |
| STS-URO-040-25 | In distribution | |
| STS-HYS-175-60-BP | In distribution | |
| STS-URO-240-10 | In distribution | |
| STS-URO-240-15 | In distribution | |
| STS-URO-040-19 | In distribution | |
| STS-URO-040-17 | In distribution | |
| STS-HYS-335-60D | In distribution | |
| STS-URO-217-ALB | In distribution | |
| STS-URO-047-26 | In distribution | |
| STS-URO-240-50 | In distribution | |
| STS-HYS-175-26-BP | In distribution | |
| STS-URO-209-26 | In distribution | |
| STS-URO-040-21 | In distribution | |
| STS-URO-100-126-QL-BP | In distribution | |
| STS-URO-240-55 | In distribution | |
| STS-URO-240-20 | In distribution | |
| STS-URO-235-60 | In distribution | |
| STS-HYS-175-DB-SL | In distribution | |
| STS-2040-302ESA | In distribution | |
| STS-HYS-340-20-BP | In distribution | |
| STS-HYS-175-08 | In distribution | |
| STS-URO-040-23 | In distribution | |
| STS-URO-001-23 | In distribution | |
| STS-HYS-340-20 | In distribution | |
| STS-URO-001-17 | In distribution | |
| STS-9040-302BSA | In distribution | |
| STS-9040-302ESA | In distribution | |
| STS-URO-035-00 | In distribution | |
| STS-HF-532-03 | In distribution | |
| STS-URO-230-24 | In distribution | |
| STS-URO-045-30 | In distribution | |
| STS-URO-225-24-BP | In distribution | |
| STS-HF-531-02 | In distribution | |
| STS-URO-2430-210-SL-KV | In distribution | |
| STS-HYS-340-10 | In distribution | |
| STS-URO-001-25-SET | In distribution | |
| STS-URO-216-ALB | In distribution | |
| STS-9040-302CA | In distribution | |
| STS-URO-001-17-SET | In distribution | |
| STS-URO-020-17 | In distribution | |
| STS-HYS-046-12 | In distribution | |
| STS-URO-001-19 | In distribution | |
| STS-HYS-309-01 | In distribution | |
| STS-URO-020-19 | In distribution | |
| STS-URO-235-60-BP-SL/BL | In distribution | |
| STS-URO-001-21 | In distribution | |
| STS-URO-100-121-QL | In distribution | |
| STS-HYS-310-22-SET | In distribution | |
| STS-2040-302BA | In distribution | |
| STS-URO-050-02 | In distribution | |
| STS-URO-340-20-SET | In distribution | |
| STS-URO-340-20-BP-SL-SET | In distribution | |
| STS-2040-302CA | In distribution | |
| STS-URO-001-16-SET | In distribution | |
| STS-URO-047-10 | In distribution | |
| STS-URO-240-40 | In distribution | |
| STS-9040-302ASA | In distribution | |
| STS-URO-240-65 | In distribution | |
| STS-URO-209-06 | In distribution | |
| STS-URO-2430-209-SL | In distribution | |
| STS-URO-001-19-SET | In distribution | |
| STS-2040-302AA | In distribution | |
| STS-HYS-340-00-BP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AED | National Advanced Endoscopy Devices, Inc. | 157 |
| 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 |
| 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 |
|---|---|
| K260271 | 2026-03-27 |
| K251652 | 2025-08-01 |
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.