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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteroscope And Accessories
510(k) Number K251204
Device Name FUJIFILM Stiffening Wire Device (SW-2000)
Applicant
FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave., Suite 100
Lexington,  MA  02421
Applicant Contact Kotei Aoki
Correspondent
FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave., Suite 100
Lexington,  MA  02421
Correspondent Contact Kotei Aoki
Regulation Number876.1500
Classification Product Code
FDA  
Date Received04/18/2025
Decision Date 09/26/2025
Decision Substantially Equivalent (SESE)
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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