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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K261880
Device Name FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01
Applicant
Fujifilm Corporation
798 Miyanodai Kaise-Machi
Ashigarakami-Gun,  JP 258-8538
Applicant Contact Chaitrali Kulkarni
Correspondent
FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave.
Suite 100
Lexington,  MA  02421
Correspondent Contact Chaitrali Kulkarni
Regulation Number876.1500
Classification Product Code
FET  
Subsequent Product Codes
FDA   FDF   NTN   NWB   PEA  
QTH  
Date Received06/05/2026
Decision Date 07/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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