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FDA 510(k)

Disposable ureteral stent

K-Number: K243830 · 2025-05-14

ApplicantShenzhen Trious Medical Technology Co., Ltd.
Decision Date2025-05-14
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable ureteral stent is a medical device manufactured by Shenzhen Trious Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-14 under approval number K243830. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable ureteral stent?

Disposable ureteral stent is a medical device that received FDA 510(k) clearance on 2025-05-14. It is manufactured by Shenzhen Trious Medical Technology Co., Ltd.. The 510(k) number is K243830.

When was Disposable ureteral stent approved by the FDA?

Disposable ureteral stent received FDA 510(k) clearance on 2025-05-14, under approval number K243830.

What company makes Disposable ureteral stent?

Disposable ureteral stent is manufactured by Shenzhen Trious Medical Technology Co., Ltd..

What is the FDA product code for Disposable ureteral stent?

The FDA product code for Disposable ureteral stent is FAD.

Related Clinical Trials

NCT07580963 Stent Related Symptoms Defined by Ureteral Stent Symptom Questionnaire in Patients With Image-Informed Ureteral Stent Lengths NOT_YET_RECRUITING NCT06719089 Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent RECRUITING NCT06045962 Optimal Stent Duration After Ureteroscopy ACTIVE_NOT_RECRUITING NCT07535580 Patient-Reported Stent Symptom Outcomes and Migration Rates Following Modified Single-J Ureteric Stent Insertion After Ureteroscopy COMPLETED

Other Devices by Shenzhen Trious Medical Technology Co., Ltd.

K250448Disposable Percutaneous Nephrostomy Dilatation Kit K243710Disposable ureteral access sheath

Related Devices (Code: FAD)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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