K250448
- 510(k) number
- K250448
- Device name
- Disposable Percutaneous Nephrostomy Dilatation Kit
- Applicant
- Shenzhen Trious Medical Technology Co., Ltd. CN
- Product code
- LJE — Catheter, Nephrostomy
- Decision date
- 2025-07-03
- Date received
- 2025-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250448.pdf
Official FDA record: K250448
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.