Uscope
This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract…
This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy. This instrument is labeled Standard Deflection.
Who Else Makes It
Concentrated in Guangdong (10), Jiangsu (3), Shanghai (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Ningbo Wise Optomech Technology Corporation | Ningbo | Zhejiang | Contract manufacturer | 4 |
| 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 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Hunan Endoso Life Technology Co., Ltd. | Xiangtan | Hunan | Manufacturer | 7 |
Showing 12 of 21. All 21 manufacturers in China registered for Ureteroscope And Accessories, Flexible/Rigid
Record
| Listed by | Zhuhai Pusen Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | FGB |
| Device type | Ureteroscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| 510(k) | K172098 |
| Record published | 2017-09-12 |
| Record revised | 2022-12-06 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | expiry date, manufacturing date, serial number |
| Packaging | Carton of 10, box of 10, box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PU3022 | In distribution | |
| PU3033AH-R | In distribution | |
| PU400A (Reverse Deflection) | In distribution | |
| PU3033A | In distribution | |
| PU3033AH (Reverse Deflection) | In distribution | |
| PU3033H (Reverse Deflection) | In distribution | |
| PU411A (Reverse Deflection) | In distribution | |
| PU400A-S | In distribution | |
| PU3033AH-S | In distribution | |
| PU3022A | In distribution | |
| PU411A-R | In distribution | |
| PU3033A-R | In distribution | |
| PU3033A-S | In distribution | |
| PU411A (Standard Deflection) | In distribution | |
| PU411A-S | In distribution | |
| PU3033AH (Standard Deflection) | In distribution | |
| PU400A (Standard Deflection) | In distribution | |
| UE3011 | In distribution | |
| PU3022A | In distribution | |
| PU3033A | In distribution | |
| PU3033H (Standard Deflection) | In distribution | |
| PU3022 | In distribution | |
| PU400A-R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ureteroscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 36 |
| SemiFlex Scope | Maxiflex, LLC | 33 |
| E-Line | Richard Wolf Gmbh | 28 |
| Olympus | Olympus Winter & IBE Gmbh | 28 |
| WiScope® | OTU Medical Inc | 16 |
| Redpine | Guangzhou RED Pine Medical Instrument Co., Ltd. | 16 |
| LithoVue | Boston Scientific Corporation | 15 |
| Single-use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | 14 |
| Dornier MedTech | Dornier Medtech America, Inc. | 12 |
| Innovex | Shanghai AnQing Medical Instrument Co., Ltd. | 12 |
| Single Use Video Ureteroscope Direct In-Scope Suction | Zhuhai Pusen Medical Technology Co., Ltd. | 12 |
| Ascend™ Single-Use Flexible Ureteroscope | Guangzhou RED Pine Medical Instrument Co., Ltd. | 12 |
Showing 12 of 75. All products under Ureteroscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233778 | 2024-07-16 |
| K172098 | 2017-08-31 |
| K171076 | 2017-05-05 |
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.