FDA 510(k)

NovoFlow Reinforced Ureteral Stent

N.º K: K213186 · 2022-02-16

Fecha de decisión2022-02-16

Código de productoFAD

Comité asesorGU

DecisiónUnknown

Resumen del dispositivo

NovoFlow Reinforced Ureteral Stent is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2022-02-16 under 510(k) number K213186. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Preguntas frecuentes

What is the NovoFlow Reinforced Ureteral Stent?

NovoFlow Reinforced Ureteral Stent is a medical device that received FDA 510(k) clearance on 2022-02-16. The listed applicant is Coloplast Corp.. The 510(k) number is K213186.

When did NovoFlow Reinforced Ureteral Stent receive FDA 510(k) clearance?

NovoFlow Reinforced Ureteral Stent received FDA 510(k) clearance on 2022-02-16, under 510(k) number K213186.

Who is the listed applicant for NovoFlow Reinforced Ureteral Stent?

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

What is the FDA product code for NovoFlow Reinforced Ureteral Stent?

The FDA product code for NovoFlow Reinforced Ureteral Stent is FAD.

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Otros registros que enlistan a Coloplast Corp. como solicitante

K252140Heylo™ System K251116Luja Coudé K250270Luja Set K242049SureCath Set K241210Luja Coude K242173Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)

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Dispositivos relacionados (Código: FAD)

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 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

Fuente oficial

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