510(k) K250448
K250448 is an FDA 510(k) premarket notification submitted by Shenzhen Trious Medical Technology Co., Ltd. for the device "Disposable Percutaneous Nephrostomy Dilatation Kit". The FDA issued a decision of Substantially Equivalent on July 3, 2025. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device. Shenzhen Trious Medical Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2025
- Date Received
- February 18, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Nephrostomy
- Device Class
- Class U
- Regulation Number
- Review Panel
- GU
- Submission Type