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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pancreatic Stent, Covered, Metallic, Removable
510(k) Number K252648
Device Name Niti-S SPAXUS 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 101
Alexandria,  VA  22314
Correspondent Contact Matthew Krueger
Regulation Number876.5015
Classification Product Code
PCU  
Subsequent Product Code
QXH  
Date Received08/21/2025
Decision Date 03/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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