| Sphincterotome (K260962) | Taewoong Medical Co., Ltd. | 2026-05-21 |
| Niti-S SPAXUS Stent (K252648) | Taewoong Medical Co., Ltd. | 2026-03-13 |
| Niti-S Biliary Stent; Niti-S Biliary Slim M Stent (K251123) | Taewoong Medical Co., Ltd. | 2025-12-29 |
| Niti-S Esophageal Stent; Esophageal TTS Stent (K243619) | Taewoong Medical Co., Ltd. | 2025-10-30 |
| Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent (K250663) | Taewoong Medical Co., Ltd. | 2025-03-31 |
| Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent (K223067) | Taewoong Medical Co., Ltd. | 2023-06-14 |
| Niti-S Biliary Speed D Stent (K223626) | Taewoong Medical Co., Ltd. | 2023-05-26 |
| Optimos™ Cystotome (K223256) | Taewoong Medical Co., Ltd. | 2023-04-05 |
| Esophageal TTS Stent (K221482) | Taewoong Medical Co., Ltd. | 2022-06-22 |
| Niti-S Biliary Slim M Stent (K221071) | Taewoong Medical Co., Ltd. | 2022-06-09 |
| Esophageal TTS Stent (K211706) | Taewoong Medical Co., Ltd. | 2021-10-08 |
| ESOPHAGEAL TTS STENT (K123205) | Taewoong Medical Co., Ltd. | 2013-10-09 |
| ESOPHAGEAL TTS STENT (K113551) | Taewoong Medical Co., Ltd. | 2012-02-14 |
| NITI-S ESOPHAGEAL STENT (K080782) | Taewoong Medical Co., Ltd. | 2009-01-30 |
| NITI-S BILIARY STENT (K073667) | Taewoong Medical Co., Ltd. | 2008-11-19 |
| NITI-S STENT & INTRODUCER, MODEL EOXXXX (K041648) | Taewoong Medical Co., Ltd. | 2005-04-28 |