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
FDA 510(k) Regulatory Record - Taewoong Medical Co., Ltd. Gastroenterology & Urology ✕
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
Cleared
Feb 14, 2012
ESOPHAGEAL TTS STENT
Gastroenterology & Urology
75d
Cleared
Jan 30, 2009
NITI-S ESOPHAGEAL STENT
Gastroenterology & Urology
317d
Cleared
Nov 19, 2008
NITI-S BILIARY STENT
Gastroenterology & Urology
329d
Cleared
Apr 28, 2005
NITI-S STENT & INTRODUCER, MODEL EOXXXX
Gastroenterology & Urology
315d