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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Esophageal
510(k) Number K243619
Device Name Niti-S Esophageal Stent; Esophageal TTS 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 Number878.3610
Classification Product Code
ESW  
Date Received11/22/2024
Decision Date 10/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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