K250448 is an FDA 510(k) clearance for the Disposable Percutaneous Nephrostomy Dilatation Kit. This device is classified as a Catheter, Nephrostomy.
Submitted by Shenzhen Trious Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 3, 2025, 135 days after receiving the submission on February 18, 2025.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K250448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2025 |
| Decision Date | July 03, 2025 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJE - Catheter, Nephrostomy |
| Device Class | - |