Taewoong Medical Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Taewoong Medical Co., Ltd. - FDA 510(k) Cleared Devices
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
Cleared
May 21, 2026
Sphincterotome
Gastroenterology & Urology
59d
Cleared
Mar 13, 2026
Niti-S SPAXUS Stent
Gastroenterology & Urology
204d
Cleared
Dec 29, 2025
Niti-S Biliary Stent
Gastroenterology & Urology
262d
Cleared
Oct 30, 2025
Niti-S Esophageal Stent
Gastroenterology & Urology
342d
Cleared
Mar 31, 2025
Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
Gastroenterology & Urology
26d
Cleared
Jun 14, 2023
Niti-S Duodenal Stent
Gastroenterology & Urology
264d
Cleared
May 26, 2023
Niti-S Biliary Speed D Stent
Gastroenterology & Urology
172d
Cleared
Apr 05, 2023
Optimos™ Cystotome
Gastroenterology & Urology
166d
Cleared
Jun 22, 2022
Esophageal TTS Stent
Gastroenterology & Urology
30d
Cleared
Jun 09, 2022
Niti-S Biliary Slim M Stent
Gastroenterology & Urology
58d
Cleared
Oct 08, 2021
Esophageal TTS Stent
Gastroenterology & Urology
127d
Cleared
Oct 09, 2013
ESOPHAGEAL TTS STENT
Gastroenterology & Urology
362d