Disposable Ureteral Stent
by Shenzhen Trious Medical Technology Co., Ltd.
510(k) K243830
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK243830 | Date14 May 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FAD
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.4620
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Disposable Ureteral Stent is a medical device classified as a ureteral stent, designed for temporary internal drainage of urine from the ureteropelvic junction to the bladder. It is intended to relieve obstruction in the urinary tract due to benign, malignant, or post-traumatic conditions by maintaining patency and facilitating urine flow.
This device is supplied as a single-use, disposable product and is regulated under FDA 510(k) clearance (K243830) as a Class 2 medical device for use in gastroenterology and urology. It is not intended for MRI use and must be stored according to manufacturer instructions to ensure sterility and functionality. Multiple reference codes (e.g., 2527072, 3021632375) identify specific variants, but no additional regulatory approvals beyond the 510(k) clearance are stated.
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Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the disposable ureteral stent?
The disposable ureteral stent is designed for temporary internal drainage of urine from the ureteropelvic junction to the bladder. Its main purpose is to relieve obstructions in the urinary tract caused by benign conditions, malignancies, or post-traumatic injuries by maintaining patency and ensuring smooth urine flow.
Is this device intended for reuse or is it single-use?
This device is explicitly supplied as a single-use, disposable product. It is not intended for reuse, which helps ensure sterility and functionality for each patient use, reducing the risk of infection or contamination.
What regulatory approval does this ureteral stent have?
The disposable ureteral stent is regulated under FDA 510(k) clearance (K243830) as a Class 2 medical device. This clearance confirms that it is substantially equivalent to a legally marketed predicate device and is approved for use in gastroenterology and urology.
Can this stent be used with MRI imaging?
No, this ureteral stent is not intended for MRI use. If MRI imaging is required, alternative non-MRI-compatible devices should be considered to avoid potential risks associated with magnetic fields.
How should the stent be stored to maintain sterility and functionality?
The stent must be stored according to the manufacturer’s instructions to preserve sterility and functionality. Proper storage conditions typically include keeping it in a sealed, sterile packaging away from direct sunlight, extreme temperatures, and moisture until ready for use.