Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003902943

FEI Number

3003902943

Entity Name

TAEWOONG MEDICAL CO., LTD

City/State/Country

Gimpo-Si Gyeonggi, KR

Establishment Address

14 Gojeong-ro, Wolgot-myeon, Gimpo-Si Gyeonggi 10022, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TAEWOONG MEDICAL CO., LTD (Owner Number: 9054381)

Owner / Operator Contact Address

14, Gojeong-ro, Wolgot-myeon, Gimpo-Si, KR-41 10022, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240522

PMA Number

N/A

All Registered Proprietary Names

Niti-S Biliary Slim M Stent Niti-S Biliary Stent Niti-S Bilary Stent Esophageal TTS Stent Snare Sphincterotome Niti-S Colonic Comfort Stent Niti-S Duodenal Comfort Stent Niti-S Colonic Comfort Stent Niti-S Duodenal Comfort Stent Guidewire Niti-S Esophageal Stent Esophageal TTS Stent Cystotome Esophageal TTS Stent Biopsy Forceps Esophageal TTS Stent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2026-01-15
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-12-04
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2012-07-26
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2022-06-29
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2026-05-25
MUM	Stent, Metallic, Expandable, Duodenal	General, Plastic Surgery	Class 2	878.3610	2023-06-18
MQR	Stent, Colonic, Metallic, Expandable	General, Plastic Surgery	Class 2	878.3610	2023-06-18
MQR	Stent, Colonic, Metallic, Expandable	General, Plastic Surgery	Class 2	878.3610	2025-11-16
MUM	Stent, Metallic, Expandable, Duodenal	General, Plastic Surgery	Class 2	878.3610	2025-11-16
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-04-03
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2009-02-18
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2022-06-23
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2023-04-13
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2021-10-12
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2010-07-13
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2024-06-13

Official Correspondent

Yongjin Kim

US Agent Details

MARGARET VERNON Business: Biologics Consulting Email: contracts@biologicsconsulting.com Phone: (720) 8833633

Related Public Records

Same Entity

TAEWOONG MEDICAL 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
K902734	Olympus Corp.	PR CANNULAS	1990-08-22
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003902943. Last updated year: 2026. Please use registration number 3003902943 when referencing this establishment in official correspondence.