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Taewoong Medical Co., Ltd.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories5
Latest FDA decision2026-05-21
TypeNumberDevice NameCodeDateActions
510(k) K260962 SphincterotomeKNS2026-05-21 View
510(k) K252648 Niti-S SPAXUS StentPCU2026-03-13 View
510(k) K251123 Niti-S Biliary Stent; Niti-S Biliary Slim M StentFGE2025-12-29 View
510(k) K243619 Niti-S Esophageal Stent; Esophageal TTS StentESW2025-10-30 View
510(k) K250663 Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentMUM2025-03-31 View
510(k) K223067 Niti-S Duodenal Stent; Niti-S Colonic Comfort StentMUM2023-06-14 View
510(k) K223626 Niti-S Biliary Speed D StentFGE2023-05-26 View
510(k) K223256 Optimos™ CystotomeKNS2023-04-05 View
510(k) K221482 Esophageal TTS StentESW2022-06-22 View
510(k) K221071 Niti-S Biliary Slim M StentFGE2022-06-09 View
510(k) K211706 Esophageal TTS StentESW2021-10-08 View
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