510(k) K250663

Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent by Taewoong Medical Co., Ltd. — Product Code MUM

K250663 is an FDA 510(k) premarket notification submitted by Taewoong Medical Co., Ltd. for the device "Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent". The FDA issued a decision of Substantially Equivalent on March 31, 2025. The device falls under product code MUM (Stent, Metallic, Expandable, Duodenal), a Class II device regulated under 21 CFR 878.3610. Taewoong Medical Co., Ltd. has at least 10 other 510(k) clearances on record.