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FDA 510(k)

HANAROSTENT Esophagus Upper (CCC)

K-Number: K253327 · 2025-10-30

ApplicantM.I.Tech Co., Ltd.
Decision Date2025-10-30
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANAROSTENT Esophagus Upper (CCC) is a medical device manufactured by M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2025-10-30 under approval number K253327. 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 Upper (CCC)?

HANAROSTENT Esophagus Upper (CCC) is a medical device that received FDA 510(k) clearance on 2025-10-30. It is manufactured by M.I.Tech Co., Ltd.. The 510(k) number is K253327.

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

HANAROSTENT Esophagus Upper (CCC) received FDA 510(k) clearance on 2025-10-30, under approval number K253327.

What company makes HANAROSTENT Esophagus Upper (CCC)?

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

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

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

Related Clinical Trials

NCT07027826 The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States RECRUITING NCT07234188 POM vs HFNC for Hypoxemia Prevention in Children COMPLETED NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING NCT07587437 Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery ENROLLING_BY_INVITATION NCT02296528 Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients TERMINATED

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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