Data / Medical devices / South Korea / Taewoong Medical Co., Ltd

Taewoong Medical Co., Ltd: FDA-registered device maker in Gimpo-Si Gyeonggi, South Korea, 16 510(k) clearances

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

Taewoong Medical Co., Ltd is registered with the FDA (registration 3003902943) in Gimpo-Si Gyeonggi, South Korea. It lists 10 device types. The FDA files 16 510(k) clearances under its listings, the newest dated May 21, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Taewoong Medical Co., Ltd

FDA registration number: 3003902943
Address: 14 Gojeong-ro, Wolgot-myeon, Gimpo-Si Gyeonggi, South Korea, 10022
Owner or operator: TAEWOONG MEDICAL CO., LTD (9054381)
Roles: Manufacturer
First device listed: December 4, 2008
Registered through: 2027
Brand names listed: Biopsy Forceps, Cystotome, Esophageal TTS Stent, Guidewire, Niti-S Bilary Stent, Niti-S Biliary Slim M Stent, Niti-S Biliary Speed D Stent, Niti-S Biliary Stent and more

Devices it lists

Device	Product code	Class	Role	Source
Endoscopic Guidewire, Gastroenterology-Urology	OCY	2	Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Manufacturer	accessdata.fda.gov
Gallbladder Drainage Stent And Delivery System	QXH	2	Manufacturer	accessdata.fda.gov
Pancreatic Stent, Covered, Metallic, Removable	PCU	2	Manufacturer	accessdata.fda.gov
Prosthesis, Esophageal	ESW	2	Manufacturer	accessdata.fda.gov
Snare, Non-Electrical	FGX	1	Manufacturer	accessdata.fda.gov
Stent, Colonic, Metallic, Expandable	MQR	2	Manufacturer	accessdata.fda.gov
Stent, Metallic, Expandable, Duodenal	MUM	2	Manufacturer	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Manufacturer	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	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
May 21, 2026	K260962	Sphincterotome	KNS	Substantially Equivalent	Taewoong Medical Co., Ltd.	accessdata.fda.gov
March 13, 2026	K252648	Niti-S SPAXUS Stent	PCU	Substantially Equivalent	Taewoong Medical Co., Ltd.	accessdata.fda.gov
December 29, 2025	K251123	Niti-S Biliary Stent; Niti-S Biliary Slim M Stent	FGE	Unknown	Taewoong Medical Co., Ltd.	accessdata.fda.gov
October 30, 2025	K243619	Niti-S Esophageal Stent; Esophageal TTS Stent	ESW	Substantially Equivalent	Taewoong Medical Co., Ltd.	accessdata.fda.gov
March 31, 2025	K250663	Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent	MUM	Substantially Equivalent	Taewoong Medical Co., Ltd.	accessdata.fda.gov
March 22, 2024	K240522	Esophageal TTS Stent	ESW	Substantially Equivalent	Taewoong Medical	accessdata.fda.gov
June 14, 2023	K223067	Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent	MUM	Substantially Equivalent	Taewoong Medical Co., Ltd.	accessdata.fda.gov
May 26, 2023	K223626	Niti-S Biliary Speed D Stent	FGE	Unknown	Taewoong Medical Co., Ltd.	accessdata.fda.gov
April 5, 2023	K223256	Optimos Cystotome	KNS	Substantially Equivalent	Taewoong Medical Co., Ltd.	accessdata.fda.gov
June 22, 2022	K221482	Esophageal TTS Stent	ESW	Substantially Equivalent	Taewoong Medical Co., Ltd.	accessdata.fda.gov
June 9, 2022	K221071	Niti-S Biliary Slim M Stent	FGE	Unknown	Taewoong Medical Co., Ltd.	accessdata.fda.gov
October 8, 2021	K211706	Esophageal TTS Stent	ESW	Substantially Equivalent	Taewoong Medical Co., Ltd.	accessdata.fda.gov
October 9, 2013	K123205	ESOPHAGEAL TTS STENT	ESW	Substantially Equivalent	Taewoong Medical Co., Ltd.	accessdata.fda.gov
February 14, 2012	K113551	ESOPHAGEAL TTS STENT	ESW	Substantially Equivalent	Taewoong Medical Co., Ltd.	accessdata.fda.gov
January 30, 2009	K080782	NITI-S ESOPHAGEAL STENT	ESW	Substantially Equivalent	Taewoong Medical Co., Ltd.	accessdata.fda.gov
November 19, 2008	K073667	NITI-S BILIARY STENT	FGE	Unknown	Taewoong Medical Co., Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 18, 2019	84742	Class II	Terminated	Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, E	Misprinted IFUs shipped with esophageal stents	accessdata.fda.gov

Compare with other makers

Updated May 21, 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.