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FDA 510(k)

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT

N.º K: K212868 · 2022-01-26

SolicitanteRocamed Sam
Fecha de decisión2022-01-26
Código de productoFAD
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT is the device name listed in this FDA 510(k) record. The listed applicant is Rocamed Sam. It received FDA 510(k) clearance on 2022-01-26 under 510(k) number K212868. 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 JFil Ureteral Stents, JFil Ureteral Stents ECO KIT?

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT is a medical device that received FDA 510(k) clearance on 2022-01-26. The listed applicant is Rocamed Sam. The 510(k) number is K212868.

When did JFil Ureteral Stents, JFil Ureteral Stents ECO KIT receive FDA 510(k) clearance?

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT received FDA 510(k) clearance on 2022-01-26, under 510(k) number K212868.

Who is the listed applicant for JFil Ureteral Stents, JFil Ureteral Stents ECO KIT?

The FDA 510(k) record lists Rocamed Sam as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JFil Ureteral Stents, JFil Ureteral Stents ECO KIT?

The FDA product code for JFil Ureteral Stents, JFil Ureteral Stents ECO KIT is FAD.

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Dispositivos relacionados (Código: FAD)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K251890Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd.K251469Endura™ Ureteral Stent and Stent SetCathegenix (Xiamen) Co., Ltd.K243039Ureteral Stents (AF-D series)Alton (Shanghai) Medical Instruments 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 CorporationK232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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