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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 K221071
Device Name Niti-S Biliary Slim M Stent
Applicant
Taewoong Medical Co., Ltd
14 Gojeong-ro, Wolgot-myeon
Gimpo-si,  KR 10022
Applicant Contact Jangsoo Lee
Correspondent
Biologics Consulting Group, Inc.
1555 King Street, Suite 300
Alexandria,  VA  22314
Correspondent Contact Matthew Krueger
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/12/2022
Decision Date 06/09/2022
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
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