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FDA 510(k)

HANAROSTENT BILIARY (NNN)

K-Number: K111149 · 2011-12-30

ApplicantM.I.Tech Co., Ltd.
Decision Date2011-12-30
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

HANAROSTENT BILIARY (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 2011-12-30 under 510(k) number K111149. 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 BILIARY (NNN)?

HANAROSTENT BILIARY (NNN) is a medical device that received FDA 510(k) clearance on 2011-12-30. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K111149.

When did HANAROSTENT BILIARY (NNN) receive FDA 510(k) clearance?

HANAROSTENT BILIARY (NNN) received FDA 510(k) clearance on 2011-12-30, under 510(k) number K111149.

Who is the listed applicant for HANAROSTENT BILIARY (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 BILIARY (NNN)?

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

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Other records listing M.I.Tech Co., Ltd. as applicant

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Related Devices (Code: FGE)

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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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