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FDA 510(k)

Ureteral Stents (AF-D series)

Número K: K243039 · 2025-06-18

RequerenteAlton (Shanghai) Medical Instruments Co., Ltd.
Data da decisão2025-06-18
Código do produtoFAD
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Ureteral Stents (AF-D series) is the device name listed in this FDA 510(k) record. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K243039. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K243039.

When did Ureteral Stents (AF-D series) receive FDA 510(k) clearance?

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

Who is the listed applicant for Ureteral Stents (AF-D series)?

The FDA 510(k) record lists Alton (Shanghai) Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Ureteral Stents (AF-D series) is FAD.

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Dispositivos Relacionados (Código: FAD)

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Fonte oficial

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