Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HANAROSTENT Esophagus Asymmetric (CCC)

K-Number: K213251 · 2021-11-18

ApplicantM.I.Tech Co., Ltd.
Decision Date2021-11-18
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANAROSTENT Esophagus Asymmetric (CCC) is the device name listed in this FDA 510(k) record. The listed applicant is M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K213251. 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 Asymmetric (CCC)?

HANAROSTENT Esophagus Asymmetric (CCC) is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K213251.

When did HANAROSTENT Esophagus Asymmetric (CCC) receive FDA 510(k) clearance?

HANAROSTENT Esophagus Asymmetric (CCC) received FDA 510(k) clearance on 2021-11-18, under 510(k) number K213251.

Who is the listed applicant for HANAROSTENT Esophagus Asymmetric (CCC)?

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 Esophagus Asymmetric (CCC)?

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

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.

K253327HANAROSTENT Esophagus Upper (CCC)K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)K202973HANAROSTENT Benefit Biliary (NNN)K201342HANAROSTENT Trachea/Bronchium (CCC)K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)K190141HANAROSTENT LowAx Colon/Rectum (NNN)

View all 11 devices →

Related Devices (Code: ESW)

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.

K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific CorporationK253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston ScientificK233837Agile Esophageal 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.

↑