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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 K223295
Device Name Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
FUJIFILM Corporaton
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun,  JP 258-8538
Applicant Contact Randy Vader
FUJIFILM Healthcare Americas Corporation
81 Hartwell Avenue, Suite 300
Lexington,  MA  02421
Correspondent Contact Kotei Aoki
Regulation Number876.1500
Classification Product Code
Subsequent Product Code
Date Received10/26/2022
Decision Date 01/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No