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

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