Medical Device Manufacturer · KR , Gyeonggi-Do

Taewoong Medical Co., Ltd. - FDA 510(k) Cleared Devices

16 submissions · 12 cleared · Since 2005

Recent clearances: Sphincterotome, Niti-S SPAXUS Stent, Niti-S Biliary Stent

16
Total
12
Cleared
0
Denied

Taewoong Medical Co., Ltd. has 12 FDA 510(k) cleared gastroenterology & urology devices. Based in Gyeonggi-Do, KR.

Latest FDA clearance: May 2026. Active since 2005.

Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Biologics Consulting Group, Inc., Biologics Consulting Group and MED Institute.

FDA 510(k) Regulatory Record - Taewoong Medical Co., Ltd.

16 devices
1-16 of 16
Cleared May 21, 2026
Sphincterotome
K260962 · KNS
Gastroenterology & Urology · 59d
Cleared Mar 13, 2026
Niti-S SPAXUS Stent
K252648 · PCU
Gastroenterology & Urology · 204d
Cleared Dec 29, 2025
Niti-S Biliary Stent
K251123 · FGE
Gastroenterology & Urology · 262d
Cleared Oct 30, 2025
Niti-S Esophageal Stent
K243619 · ESW
Gastroenterology & Urology · 342d
Cleared Mar 31, 2025
Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
K250663 · MUM
Gastroenterology & Urology · 26d
Cleared Jun 14, 2023
Niti-S Duodenal Stent
K223067 · MUM
Gastroenterology & Urology · 264d
Cleared May 26, 2023
Niti-S Biliary Speed D Stent
K223626 · FGE
Gastroenterology & Urology · 172d
Cleared Apr 05, 2023
Optimos™ Cystotome
K223256 · KNS
Gastroenterology & Urology · 166d
Cleared Jun 22, 2022
Esophageal TTS Stent
K221482 · ESW
Gastroenterology & Urology · 30d
Cleared Jun 09, 2022
Niti-S Biliary Slim M Stent
K221071 · FGE
Gastroenterology & Urology · 58d
Cleared Oct 08, 2021
Esophageal TTS Stent
K211706 · ESW
Gastroenterology & Urology · 127d
Cleared Oct 09, 2013
ESOPHAGEAL TTS STENT
K123205 · ESW
Gastroenterology & Urology · 362d
Cleared Feb 14, 2012
ESOPHAGEAL TTS STENT
K113551 · ESW
Gastroenterology & Urology · 75d
Cleared Jan 30, 2009
NITI-S ESOPHAGEAL STENT
K080782 · ESW
Gastroenterology & Urology · 317d
Cleared Nov 19, 2008
NITI-S BILIARY STENT
K073667 · FGE
Gastroenterology & Urology · 329d
Cleared Apr 28, 2005
NITI-S STENT & INTRODUCER, MODEL EOXXXX
K041648 · ESW
Gastroenterology & Urology · 315d
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