Data / Medical devices / China / Zhuhai Pusen Medical Technology Co., Ltd.
Zhuhai Pusen Medical Technology Co., Ltd.: FDA-registered device maker in Zhuhai Guangdong, China, 6 510(k) clearances
Zhuhai Pusen Medical Technology Co., Ltd. is registered with the FDA (registration 3036978610) in Zhuhai Guangdong, China. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 6, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036978610
- Address
- No. 1118, Jinrui Yi Road, High-tech Zone, Zhuhai Guangdong, China, 519085
- Owner or operator
- Zhuhai Pusen Medical Technology Co., Ltd. (10055280)
- Roles
- Manufacturer
- First device listed
- September 4, 2017
- Registered through
- 2026
- Brand names listed
- BL100, ClearEVAC Ureteral Aspirating Access Sheath, Eview, HD Medical Video Endoscope Image Processor (models: PV300, PVX800), PU3033AH-S, PU3033AH-R, PU3033H-S, PU3033H-R Single Use Video Ureteroscope Direct In-Scope Suction, PU400A-S, PU400A-R, PU411A-S, PU411A-R Single Use Video Ureteroscope Direct In-Scope Suction, PU630A-S, PU630A-R, PU632A-S, PU632A-R Single Use Video Ureteroscope Direct In-Scope Suction, PU631A-S, PU631A-R, PU633A-S, PU633A-R Single Use Flexible Video Ureteroscope and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Choledochoscope And Accessories, Flexible/Rigid | FBN | 2 | Manufacturer | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 2 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 6, 2026 | K260521 | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) | FED | Substantially Equivalent | Zhuhai Pusen Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 16, 2024 | K233778 | Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) | FGB | Substantially Equivalent | Zhuhai Pusen Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 22, 2023 | K223741 | Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300) | FBN | Substantially Equivalent | Zhuhai Pusen Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 26, 2022 | K222602 | Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300) | FAJ | Substantially Equivalent | Zhuhai Pusen Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 29, 2019 | K190648 | Pusen Eview Medical Video Endoscope Image Processor | FET | Substantially Equivalent | Zhuhai Pusen Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 31, 2017 | K172098 | Medical Video Endoscope System | FGB | Substantially Equivalent | Zhuhai Pusen Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Ureteroscope And Accessories, Flexible/Rigid
- All makers of Cystoscope And Accessories, Flexible/Rigid
- All makers of Endoscopic Access Overtube, Gastroenterology-Urology
- All makers of Laryngoscope, Rigid
- All makers of Choledochoscope And Accessories, Flexible/Rigid
- All makers of Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
Updated April 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.