Data / Medical devices / South Korea / Finemedix

Finemedix: FDA-registered device maker in Daegu Gwangyeogsi, South Korea, 10 510(k) clearances

Name: Finemedix FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Finemedix is registered with the FDA (registration 3012042439) in Daegu Gwangyeogsi, South Korea. It lists 11 device types. The FDA files 10 510(k) clearances under its listings, the newest dated April 16, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3012042439
Address: 140-9, Yuram-ro, Dong-gu, Daegu Gwangyeogsi, South Korea, 41059
Owner or operator: FINEMEDIX CO., LTD. (10056774)
Roles: Manufacturer
First device listed: January 15, 2018
Registered through: 2027
Brand names listed: Clear-Bite Biopsy Forceps, Clear-Jet Injection Catheter, ClearCap Distal Attachment, ClearEndoclip, ClearGrasp Snare, ClearHemograsper, ClearTip, ClearTip FNA and FNB Types and more

Devices it lists

Device	Product code	Class	Role	Source
Biopsy Needle	FCG	2	Manufacturer	accessdata.fda.gov
Bronchoscope Accessory	KTI	2	Manufacturer	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Manufacturer	accessdata.fda.gov
Endoscopic Irrigation/Suction System	OCX	2	Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Electric	KGE	2	Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Manufacturer	accessdata.fda.gov
Hemostatic Metal Clip For The Gi Tract	PKL	2	Manufacturer	accessdata.fda.gov
Ligator, Esophageal	MND	2	Manufacturer	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Manufacturer	accessdata.fda.gov
Snare, Flexible	FDI	2	Manufacturer	accessdata.fda.gov
Snare, Non-Electrical	FGX	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 16, 2026	K251478	ClearTip TBNA Type	KTI	Substantially Equivalent	Finemedix Co., Ltd.	accessdata.fda.gov
August 21, 2025	K250994	ClearTip FNA and FNB Types	FCG	Substantially Equivalent	Finemedix Co., Ltd.	accessdata.fda.gov
May 21, 2025	K242857	ClearHemograsper	KGE	Substantially Equivalent	Finemedix Co., Ltd.	accessdata.fda.gov
August 20, 2024	K242134	ClearCap Distal Attachment	OCX	Substantially Equivalent	Finemedix Co., Ltd.	accessdata.fda.gov
June 30, 2023	K231267	ClearTip	FCG	Substantially Equivalent	Finemedix Co., Ltd.	accessdata.fda.gov
February 19, 2021	K202616	ClearCap Distal Attachment	OCX	Substantially Equivalent	Finemedix Co., Ltd.	accessdata.fda.gov
October 5, 2020	K200217	ClearEndoclip	PKL	Substantially Equivalent	Finemedix Co., Ltd.	accessdata.fda.gov
March 6, 2019	K183289	ClearGrasp Snare	FDI	Substantially Equivalent	Finemedix Co., Ltd.	accessdata.fda.gov
December 21, 2018	K181690	Clear-Jet Injection Catheter	FBK	Substantially Equivalent	Finemedix Co., Ltd.	accessdata.fda.gov
November 1, 2018	K180363	Clear-Tip EUS-FNA	FCG	Substantially Equivalent	Finemedix Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.