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FDA 510(k)

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

K-Number: K200860 · 2020-05-20

ApplicantM.I.Tech Co., Ltd.
Decision Date2020-05-20
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) is a medical device manufactured by M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2020-05-20 under approval number K200860. 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 TTS (CCC), HANAROSTENT Esophagus TTS (NCN)?

HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) is a medical device that received FDA 510(k) clearance on 2020-05-20. It is manufactured by M.I.Tech Co., Ltd.. The 510(k) number is K200860.

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

HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) received FDA 510(k) clearance on 2020-05-20, under approval number K200860.

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

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

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

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

Other Devices by M.I.Tech Co., Ltd.

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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. K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation K213251HANAROSTENT Esophagus Asymmetric (CCC)M.I.Tech Co., Ltd.

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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