Zhuhai Pusen Medical Technology Co., Ltd.
Zhuhai Guangdong, CN
Zhuhai Pusen Medical Technology Co., Ltd. appears in FDA device records in Zhuhai Guangdong, CN. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Zhuhai Pusen Medical Technology Co., Ltd. between 2017 and 2026. The busiest year on record is 2017, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 2 |
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260521 | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) | FED | Substantially Equivalent | |
| K233778 | Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) | FGB | Substantially Equivalent | |
| 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 | |
| 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 | |
| K190648 | Pusen Eview Medical Video Endoscope Image Processor | FET | Substantially Equivalent | |
| K172098 | Medical Video Endoscope System | FGB | Substantially Equivalent | |
| K171076 | Medical Video Endoscope System | FGB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3036978610 | 3036978610 | Zhuhai Pusen Medical Technology Co., Ltd. | No. 1118, Jinrui Yi Road, High-tech Zone, Zhuhai Guangdong 519085 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FBNCholedochoscope And Accessories, Flexible/Rigid
- FAJCystoscope And Accessories, Flexible/Rigid
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- CCWLaryngoscope, Rigid
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain