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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 K233321
Device Name Double Balloon Endoscope EN-840T, Over-tube TS-1214C
Applicant
Fujifilm Healthcare Americas Corporation
81 Hartwell Ave.
Suite 300
Lexington,  MA  02421
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
FDA  
Date Received09/29/2023
Decision Date 06/13/2024
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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