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FDA 510(k)

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

K-Number: K201160 · 2021-07-23

ApplicantM.I.Tech Co., Ltd.
Decision Date2021-07-23
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) is a medical device manufactured by M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2021-07-23 under approval number K201160. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)?

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) is a medical device that received FDA 510(k) clearance on 2021-07-23. It is manufactured by M.I.Tech Co., Ltd.. The 510(k) number is K201160.

When was HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) approved by the FDA?

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) received FDA 510(k) clearance on 2021-07-23, under approval number K201160.

What company makes HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)?

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) is manufactured by M.I.Tech Co., Ltd..

What is the FDA product code for HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)?

The FDA product code for HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) is ESW.

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: ESW)

K162717Evolution Esophageal Stent System – Partially CoveredCook Ireland, Ltd. K180144Agile Esophageal Stent SystemBoston Scientific Corporation K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K182910Segmented Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd. K211960Agile Esophageal OTW Stent SystemBoston 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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