Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011458193

FEI Number

3011458193

Entity Name

M.I.Tech Co., Ltd.

City/State/Country

Seoul, KR

Establishment Address

458, Bongeunsa-ro, Gangnam-gu, Seoul 06154, KR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

M.I.Tech Co., Ltd. (Owner Number: 10030918)

Owner / Operator Contact Address

174, habuk 2gil, jinwimyeon, Pyeongtaek, KR-41 17706, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202973

PMA Number

N/A

All Registered Proprietary Names

HANAROSTENT LowAX Colon/Rectum(NNN) HANAROSTENT LowAx Duodenum/Pylorus(NNN) HANAROSTENT® Esophagus (CCC), HANAROSTENT® Esophagus (NCN) HANAROSTENT Esophagus Upper (CCC) HANAROSTENT® FAST Biliary (NNN) HANAROSTENT® Esophageal TTS (NCN) HANAROSTENT® Esophageal TTS (CCC) HANAROSTENT LowAx Duodenum/Pylorus (NNN) HANAROSTENT LowAx Colon/Rectum (NNN) HANAROSTENT® Trachea/Bronchium (CCC) HANAROSTENT® Esophagus Asymmetric (CCC) HANAROSTENT® Benefit Biliary (NNN)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQR	Stent, Colonic, Metallic, Expandable	General, Plastic Surgery	Class 2	878.3610	2019-03-08
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2021-07-26
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2025-12-16
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2019-02-11
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2020-05-22
MQR	Stent, Colonic, Metallic, Expandable	General, Plastic Surgery	Class 2	878.3610	2019-01-11
MUM	Stent, Metallic, Expandable, Duodenal	General, Plastic Surgery	Class 2	878.3610	2019-01-11
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2021-01-03
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2021-11-23
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2021-05-18

Official Correspondent

Jaioh Kwak

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

M.I.Tech Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3040096051	M.I.TECH CO., LTD.	Jeonju Jeonbuk, KR
3008146331	M.I.Tech Co Ltd	Pyeongtaek Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K902734	Olympus Corp.	PR CANNULAS	1990-08-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-05	N/A	2	Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011	Navilyst Medical, Inc	2	Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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3005099803	BOSTON SCIENTIFIC CORPORATION	Marlborough, MA, US
3040096051	M.I.TECH CO., LTD.	Jeonju Jeonbuk, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011458193. Last updated year: 2026. Please use registration number 3011458193 when referencing this establishment in official correspondence.