FDA 510(k)

WallFlex Colonic Stent System with Anchor Lock Delivery System

N.º K: K201159 · 2020-08-17

SolicitanteBoston Scientific Corporation

Fecha de decisión2020-08-17

Código de productoMQR

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

WallFlex Colonic Stent System with Anchor Lock Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-08-17 under 510(k) number K201159. The device is classified under product code MQR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the WallFlex Colonic Stent System with Anchor Lock Delivery System?

WallFlex Colonic Stent System with Anchor Lock Delivery System is a medical device that received FDA 510(k) clearance on 2020-08-17. The listed applicant is Boston Scientific Corporation. The 510(k) number is K201159.

When did WallFlex Colonic Stent System with Anchor Lock Delivery System receive FDA 510(k) clearance?

WallFlex Colonic Stent System with Anchor Lock Delivery System received FDA 510(k) clearance on 2020-08-17, under 510(k) number K201159.

Who is the listed applicant for WallFlex Colonic Stent System with Anchor Lock Delivery System?

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

What is the FDA product code for WallFlex Colonic Stent System with Anchor Lock Delivery System?

The FDA product code for WallFlex Colonic Stent System with Anchor Lock Delivery System is MQR.

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Dispositivos relacionados (Código: MQR)

K234046WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery SystemBoston Scientific Corporation K200257WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery SystemBoston Scientific Corporation K190141HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd.K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.

Fuente oficial

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