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

FDA 510(k)

HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)

K-Number: K180180 · 2018-11-02

ApplicantM.I.Tech Co., Ltd.
Decision Date2018-11-02
Product CodeMQR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is a medical device manufactured by M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2018-11-02 under approval number K180180. The device is classified under product code MQR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)?

HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by M.I.Tech Co., Ltd.. The 510(k) number is K180180.

When was HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) approved by the FDA?

HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) received FDA 510(k) clearance on 2018-11-02, under approval number K180180.

What company makes HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)?

HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is manufactured by M.I.Tech Co., Ltd..

What is the FDA product code for HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)?

The FDA product code for HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is MQR.

Related Clinical Trials

NCT06133387 PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System RECRUITING NCT07146165 Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM) RECRUITING

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

K160893HANAROCare ReJu K190141HANAROSTENT LowAx Colon/Rectum (NNN) K183396HANAROSTENT FASTTM Biliary (NNN) K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) K201342HANAROSTENT Trachea/Bronchium (CCC) K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)

View all 11 devices →

Related Devices (Code: MQR)

K190141HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd. K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd. K201159WallFlex Colonic Stent System with Anchor Lock Delivery SystemBoston Scientific Corporation K200257WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery SystemBoston Scientific Corporation K234046WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery 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.

↑