Zhuhai Pusen Medical Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Zhuhai Pusen Medical Technology Co., Ltd.” (first 2017, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 48 days. Since 2017 the median was 48 days, against 135 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 2 | 38 |
| 2018 | 0 | — |
| 2019 | 1 | 16 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 28 |
| 2023 | 1 | 190 |
| 2024 | 1 | 232 |
| 2025 | 0 | — |
| 2026 | 1 | 48 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zhuhai Pusen Medical Technology Co., Ltd. took a median 48 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 135 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 3 | 3 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
Review panels
Most recent Zhuhai Pusen Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260521 | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) | FED | 2026-04-06 | 48 |
| K233778 | Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) | FGB | 2024-07-16 | 232 |
| 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 | 2023-06-22 | 190 |
| 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 | 2022-09-26 | 28 |
| K190648 | Pusen Eview Medical Video Endoscope Image Processor | FET | 2019-03-29 | 16 |
| K172098 | Medical Video Endoscope System | FGB | 2017-08-31 | 51 |
| K171076 | Medical Video Endoscope System | FGB | 2017-05-05 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Zhuhai Pusen Medical Technology Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Zhuhai Yueja Medical Device Technology Co., Ltd. (3 510(k)s)
- Zhuhai Dipu Medical Technology Co., Ltd. (2 510(k)s)
- Zhuhai DR Medical Instruments Co., Ltd. (2 510(k)s)
- Zhuhai Linte Medical Instrument Co., Ltd. (2 510(k)s)
- Zhuhai Fitlens Medical Technology Co., Ltd. (1 510(k)s)
- Zhuhai Gaoge Medical Technology Co., Ltd. (1 510(k)s)
- Zhuhai Gold Class , Ltd. (1 510(k)s)
- Zhuhai Herald Datanetics Limited. (1 510(k)s)
- Zhuhai Siger Medical Equipment Co., Ltd. (1 510(k)s)
- Zhuhai Wesee Meditech Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zhuhai Pusen Medical Technology Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Zhuhai Pusen Medical Technology Co., Ltd.” (first 2017, latest 2026), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Zhuhai Pusen Medical Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zhuhai Pusen Medical Technology Co., Ltd. is 48 days. Since 2017: 48 days, versus 135 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zhuhai Pusen Medical Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are FGB (Ureteroscope And Accessories, Flexible/Rigid, 3); FAJ (Cystoscope And Accessories, Flexible/Rigid, 1); FBN (Choledochoscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 7 Zhuhai Pusen Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FGB, Zhuhai Pusen Medical Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.