Disposable ureteral stent— 510(k) K243830
Substantially EquivalentShenzhen Trious Medical Technology Co., Ltd.
FDA 510(k) clearance K243830 for Disposable ureteral stent, Substantially Equivalent on 2025-05-14. Applicant: Shenzhen Trious Medical Technology Co., Ltd..
Clearance details
- Applicant
- Shenzhen Trious Medical Technology Co., Ltd.
- Product code
- Code FAD
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Adverse events under product code FAD
product code FAD- Death
- 2
- Injury
- 858
- Malfunction
- 2,651
- Other
- 1
- Total
- 3,512
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.