FINEMEDIX

FDA Device Registration & Listing · Daegu Gwangyeogsi, KR · Registration 3012042439

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
3012042439
FEI Number
3012042439
Entity Name
FINEMEDIX
City/State/Country
Daegu Gwangyeogsi, KR
Establishment Address
140-9, Yuram-ro, Dong-gu, Daegu Gwangyeogsi 41059, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
FINEMEDIX CO., LTD. (Owner Number: 10056774)
Owner / Operator Contact Address
140-9, Yuram-ro, Dong-gu, Daegu Gwangyeogsi, KR-27 41059, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K250994
PMA Number
N/A

All Registered Proprietary Names

Clear-Bite Biopsy Forceps ClearGrasp Snare ClearCap Distal Attachment ClearTip Clear-Jet Injection Catheter ClearGrasp Snare ClearCap Distal Attachment ClearTip TBNA Type ClearTip ClearHemograsper ClearEndoclip ClearTip FNA and FNB Types

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2018-01-15
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2019-04-06
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2024-10-16
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2018-11-02
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2019-01-03
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2019-01-24
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2021-02-21
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2026-04-20
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2023-07-02
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2025-05-27
MND Ligator, Esophageal Gastroenterology, Urology Class 2 876.4400 2020-10-13
FHN Ligator, Hemorrhoidal Gastroenterology, Urology Class 2 876.4400 2020-10-13
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2020-10-13
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2025-08-25

Official Correspondent

Heon-sik Lee

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 2025789

Related Public Records

Same Entity

FINEMEDIX CO., LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K200745 United States Endoscopy Group, Inc. Lariat, Hot/Cold Snare 2020-04-21
K150891 Covidien, LLC( Formerly Beacon Endoscopic Corp.) BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System 2015-05-01
K000397 Boston Scientific Corp SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL 2000-03-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2016 US Endoscopy Group Inc 2
Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
Z-0010-2023 Hobbs Medical, Inc. 2
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023 Hobbs Medical, Inc. 2
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
Z-0029-2012 Olympus America Inc. 2
OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
Z-0020-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4702

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012042439. Last updated year: 2026. Please use registration number 3012042439 when referencing this establishment in official correspondence.
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