FDA 510(k)

Ureteral Stents (AF-D series)

N.º K: K243039 · 2025-06-18

SolicitanteAlton (Shanghai) Medical Instruments Co., Ltd.

Fecha de decisión2025-06-18

Código de productoFAD

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Alton (Shanghai) Medical Instruments Co., Ltd. como solicitante

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

Dispositivos relacionados (Código: FAD)

K251890Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd.K251469Endura™ Ureteral Stent and Stent SetCathegenix (Xiamen) Co., Ltd.K243830Disposable ureteral stentShenzhen Trious Medical Technology Co., Ltd.K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent SetBoston Scientific Corporation K232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company K211934Sistema de Catéter de Drenaje APDL, Sistema de Catéter de Drenaje Flexima APDL, Kit de Catéter de Drenaje Flexima APDL con Punta Disoluble, Sistema de Catéter de Drenaje Flexima APDL con Punta Disoluble, Sistema de Catéter de Drenaje Flexima APD, Kit de Catéter de Drenaje Flexima APD, Sistema de Catéter de Drenaje Flexima APD con Punta Disoluble, Kit de Catéter de Drenaje Flexima APD con Punta Disoluble, Sistema de Catéter de Drenaje Rápido Flexima, Sistema de Catéter de Drenaje vanSonnenberg, Catéter vanSonnenbergBoston Scientific Corporation

Fuente oficial

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