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FDA 510(k)

HANAROSTENT FASTTM Biliary (NNN)

K-Number: K183396 · 2019-02-11

ApplicantM.I.Tech Co., Ltd.
Decision Date2019-02-11
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

HANAROSTENT FASTTM Biliary (NNN) is a medical device manufactured by M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2019-02-11 under approval number K183396. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the HANAROSTENT FASTTM Biliary (NNN)?

HANAROSTENT FASTTM Biliary (NNN) is a medical device that received FDA 510(k) clearance on 2019-02-11. It is manufactured by M.I.Tech Co., Ltd.. The 510(k) number is K183396.

When was HANAROSTENT FASTTM Biliary (NNN) approved by the FDA?

HANAROSTENT FASTTM Biliary (NNN) received FDA 510(k) clearance on 2019-02-11, under approval number K183396.

What company makes HANAROSTENT FASTTM Biliary (NNN)?

HANAROSTENT FASTTM Biliary (NNN) is manufactured by M.I.Tech Co., Ltd..

What is the FDA product code for HANAROSTENT FASTTM Biliary (NNN)?

The FDA product code for HANAROSTENT FASTTM Biliary (NNN) is FGE.

Other Devices by M.I.Tech Co., Ltd.

K160893HANAROCare ReJu K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) K190141HANAROSTENT LowAx Colon/Rectum (NNN) K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) K201342HANAROSTENT Trachea/Bronchium (CCC) K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)

View all 11 devices →

Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K161203Soehendra Stent RetrieverWilson-Cook Medical, Inc. K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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