M.I.Tech Co Ltd

FDA Device Registration & Listing · Pyeongtaek Gyeonggi, KR · Registration 3008146331

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008146331
FEI Number
3008146331
Entity Name
M.I.Tech Co Ltd
City/State/Country
Pyeongtaek Gyeonggi, KR
Establishment Address
174, Habuk 2gil, Jinwimyeon, Pyeongtaek Gyeonggi 17706, KR
Establishment Type(s)
Manufacture Medical Device
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
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2021-07-26
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2020-05-22
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
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
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 2025-12-16

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
3011458193 M.I.Tech Co., Ltd. Seoul, KR
3040096051 M.I.TECH CO., LTD. Jeonju Jeonbuk, 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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1225687 Boston Scientific Corp., Marina Bay Cust. Fulfillment Center QUINCY, MA, US
3011458193 M.I.Tech Co., Ltd. Seoul, KR
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008146331. Last updated year: 2026. Please use registration number 3008146331 when referencing this establishment in official correspondence.
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