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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K251123
Device Name Niti-S Biliary Stent; Niti-S Biliary Slim M Stent
Applicant
Taewoong Medical Co., Ltd.
14, Gojeong-Ro
Wolgot-Myeon, Gimpo-Si
Gyeonggi-Do,  KR 10022
Applicant Contact Yongjin "Jeff" Kim
Correspondent
Biologics Consulting Group
100 Daingerfield Rd.
Suite 400
Alexandria,  VA  22314
Correspondent Contact Matthew Krueger
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/11/2025
Decision Date 12/29/2025
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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