Data / Medical devices / United States / Pusen Usa Inc
Pusen Usa Inc: FDA-registered device maker in Johns Creek, GA, United States, 3 510(k) clearances
Pusen Usa Inc is registered with the FDA (registration 3029981244) in Johns Creek, GA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 26, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029981244
- Address
- 11340 Lakefield Drive Suite 200, Johns Creek, GA, United States, 30097
- Owner or operator
- PUSEN USA Inc (10089223)
- Roles
- Complaint file establishment
- First device listed
- November 16, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Complaint file establishment | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| 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 |
| August 31, 2017 | K172098 | Medical Video Endoscope System | FGB | Substantially Equivalent | Zhuhai Pusen Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 5, 2017 | K171076 | 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
Updated September 26, 2022. 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.