FDA 510(k)

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

N.º K: K183616 · 2019-01-10

Fecha de decisión2019-01-10

Código de productoMQR

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx 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 2019-01-10 under 510(k) number K183616. 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 LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)?

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K183616.

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

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) received FDA 510(k) clearance on 2019-01-10, under 510(k) number K183616.

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

The FDA product code for HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx 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.K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.

Fuente oficial

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