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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Duodenoscope And Accessories, Flexible/Rigid
510(k) Number K251861
Device Name FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
Applicant
Fujifilm Corporation
798 Miyanodai Kaisei-Machi
Ashigara Kami-Gun,  JP 258-8538
Applicant Contact Chaitrali Kulkarni
Correspondent
FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave.
Suite 300
Lexington,  MA  02421
Correspondent Contact Chaitrali Kulkarni
Regulation Number876.1500
Classification Product Code
FDT  
Subsequent Product Code
FET  
Date Received06/17/2025
Decision Date 03/09/2026
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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