K243025
- 510(k) number
- K243025
- Device name
- Ureteral Access Sheath
- Applicant
- Seplou (Zhuhai) Co., Ltd. CN
- Product code
- FED — Endoscopic Access Overtube, Gastroenterology-Urology
- Decision date
- 2025-01-30
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243025.pdf
Official FDA record: K243025
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.