K250695
- 510(k) number
- K250695
- Device name
- Single-use Ureteral Access Sheath
- Applicant
- Shenzhen HugeMed Medical Technical Development Co., Ltd. CN
- Product code
- FED — Endoscopic Access Overtube, Gastroenterology-Urology
- Decision date
- 2025-07-08
- Date received
- 2025-03-07
- 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: K250695.pdf
Official FDA record: K250695
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.