FDA 510(k)

HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)

N.º K: K180180 · 2018-11-02

Fecha de decisión2018-11-02

Código de productoMQR

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is the device name listed in this FDA 510(k) record. The listed applicant is M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K180180. 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 HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)?

HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K180180.

When did HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) receive FDA 510(k) clearance?

HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) received FDA 510(k) clearance on 2018-11-02, under 510(k) number K180180.

Who is the listed applicant for HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)?

The FDA 510(k) record lists M.I.Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)?

The FDA product code for HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is MQR.

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Otros registros que enlistan a M.I.Tech Co., Ltd. como solicitante

K253327HANAROSTENT Esophagus Upper (CCC)K213251HANAROSTENT Esophagus Asymmetric (CCC)K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)K202973HANAROSTENT Benefit Biliary (NNN)K201342HANAROSTENT Trachea/Bronchium (CCC)K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)

Ver todos los 11 dispositivos →

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 K201159WallFlex Colonic 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.

Fuente oficial

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