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FDA 510(k)

HANAROSTENT Trachea/Bronchium (CCC)

K-Number: K201342 · 2020-12-31

ApplicantM.I.Tech Co., Ltd.
Decision Date2020-12-31
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANAROSTENT Trachea/Bronchium (CCC) is a medical device manufactured by M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2020-12-31 under approval number K201342. The device is classified under product code JCT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANAROSTENT Trachea/Bronchium (CCC)?

HANAROSTENT Trachea/Bronchium (CCC) is a medical device that received FDA 510(k) clearance on 2020-12-31. It is manufactured by M.I.Tech Co., Ltd.. The 510(k) number is K201342.

When was HANAROSTENT Trachea/Bronchium (CCC) approved by the FDA?

HANAROSTENT Trachea/Bronchium (CCC) received FDA 510(k) clearance on 2020-12-31, under approval number K201342.

What company makes HANAROSTENT Trachea/Bronchium (CCC)?

HANAROSTENT Trachea/Bronchium (CCC) is manufactured by M.I.Tech Co., Ltd..

What is the FDA product code for HANAROSTENT Trachea/Bronchium (CCC)?

The FDA product code for HANAROSTENT Trachea/Bronchium (CCC) is JCT.

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) K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)

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Related Devices (Code: JCT)

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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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