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FDA 510(k)

HANAROSTENT Benefit Biliary (NNN)

K-Number: K202973 · 2021-05-11

Decision Date2021-05-11
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

HANAROSTENT Benefit 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 2021-05-11 under 510(k) 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. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K202973.

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

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

Who is the listed applicant for HANAROSTENT Benefit 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 Benefit Biliary (NNN)?

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

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 11 devices →

Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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