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FDA 510(k)

Endura™ Ureteral Stent and Stent Set

K-Number: K251469 · 2025-12-19

ApplicantCathegenix (Xiamen) Co., Ltd.
Decision Date2025-12-19
Product CodeFAD
Advisory CommitteeGU
DecisionUnknown

Device Summary

Endura™ Ureteral Stent and Stent Set is a medical device manufactured by Cathegenix (Xiamen) Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under approval number K251469. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Endura™ Ureteral Stent and Stent Set?

Endura™ Ureteral Stent and Stent Set is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Cathegenix (Xiamen) Co., Ltd.. The 510(k) number is K251469.

When was Endura™ Ureteral Stent and Stent Set approved by the FDA?

Endura™ Ureteral Stent and Stent Set received FDA 510(k) clearance on 2025-12-19, under approval number K251469.

What company makes Endura™ Ureteral Stent and Stent Set?

Endura™ Ureteral Stent and Stent Set is manufactured by Cathegenix (Xiamen) Co., Ltd..

What is the FDA product code for Endura™ Ureteral Stent and Stent Set?

The FDA product code for Endura™ Ureteral Stent and Stent Set 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 Cathegenix (Xiamen) Co., Ltd.

K250585LumenaTM Ureteral Access Sheath

Related Devices (Code: FAD)

K163068pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation K161277ConvertX Nephroureteral Stent SystemBrightwater Medical K160891Ultrathane Endoureterotomy Stent SetCook Incorporated K151051Universa Soft Ureteral Stents and Stent SetsCook Incorporated K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTSColoplast Corp. K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTSColoplast Corp.

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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