K260521
- 510(k) number
- K260521
- Device name
- ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
- Applicant
- Zhuhai Pusen Medical Technology Co., Ltd. CN
- Product code
- FED — Endoscopic Access Overtube, Gastroenterology-Urology
- Decision date
- 2026-04-06
- Date received
- 2026-02-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K260521.pdf
Official FDA record: K260521
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.