K233778
- 510(k) number
- K233778
- Device name
- Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
- Applicant
- Zhuhai Pusen Medical Technology Co., Ltd. CN
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-07-16
- Date received
- 2023-11-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K233778.pdf
Official FDA record: K233778
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.