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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Device For Endoscopic Gastrointestinal Use
510(k) Number K240994
Device Name Nexpowder
Applicant
Nextbiomedical Co., Ltd.
6, Venture-Ro 100beon-Gil, Yeonsu-Gu
Incheon,  KR 22013
Applicant Contact Kim Suji
Correspondent
Covidien, LLC
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact Gali Shrieber
Regulation Number878.4456
Classification Product Code
QAU  
Date Received04/11/2024
Decision Date 11/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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