HANAROSTENT FASTTM Biliary (NNN)
K-Number: K183396 · 2019-02-11
Device Summary
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. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K183396.
When did HANAROSTENT FASTTM Biliary (NNN) receive FDA 510(k) clearance?
HANAROSTENT FASTTM Biliary (NNN) received FDA 510(k) clearance on 2019-02-11, under 510(k) number K183396.
Who is the listed applicant for HANAROSTENT FASTTM 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 FASTTM Biliary (NNN)?
The FDA product code for HANAROSTENT FASTTM 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.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.