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FDA 510(k)

Ureteral Stents (AF-D series)

K-Number: K243039 · 2025-06-18

ApplicantAlton (Shanghai) Medical Instruments Co., Ltd.
Decision Date2025-06-18
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ureteral Stents (AF-D series) is a medical device manufactured by Alton (Shanghai) Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-06-18 under approval number K243039. 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 Ureteral Stents (AF-D series)?

Ureteral Stents (AF-D series) is a medical device that received FDA 510(k) clearance on 2025-06-18. It is manufactured by Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K243039.

When was Ureteral Stents (AF-D series) approved by the FDA?

Ureteral Stents (AF-D series) received FDA 510(k) clearance on 2025-06-18, under approval number K243039.

What company makes Ureteral Stents (AF-D series)?

Ureteral Stents (AF-D series) is manufactured by Alton (Shanghai) Medical Instruments Co., Ltd..

What is the FDA product code for Ureteral Stents (AF-D series)?

The FDA product code for Ureteral Stents (AF-D series) 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 NCT06045962 Optimal Stent Duration After Ureteroscopy ACTIVE_NOT_RECRUITING

Other Devices by Alton (Shanghai) Medical Instruments Co., Ltd.

K230925Disposable Injection Needle AF series K241285Disposable Endoscope Valves Set (AF series) K231633Disposable Hemoclip (AF series) K242635Endoscopic Distal Attachment (AF-D series) K241679Disposable Cytology Brush (AF series)

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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