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FDA 510(k)

HANAROSTENT Benefit Biliary (NNN)

K-Number: K202973 · 2021-05-11

ApplicantM.I.Tech Co., Ltd.
Decision Date2021-05-11
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

HANAROSTENT Benefit Biliary (NNN) is a medical device manufactured by M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2021-05-11 under approval number K202973. 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 Benefit Biliary (NNN)?

HANAROSTENT Benefit Biliary (NNN) is a medical device that received FDA 510(k) clearance on 2021-05-11. It is manufactured by M.I.Tech Co., Ltd.. The 510(k) number is K202973.

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

HANAROSTENT Benefit Biliary (NNN) received FDA 510(k) clearance on 2021-05-11, under approval number K202973.

What company makes HANAROSTENT Benefit Biliary (NNN)?

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

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

The FDA product code for HANAROSTENT Benefit 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) K183396HANAROSTENT FASTTM Biliary (NNN) K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) K201342HANAROSTENT Trachea/Bronchium (CCC)

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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