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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K230752
Device Name Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
Applicant
Fujifilm Healthcare Americas Corporation
81 Hartwell Avenue
Suite 300
Lexington,  MA  02421
Applicant Contact Kotei Aoki
Correspondent
Fujifilm Healthcare Americas Corporation
81 Hartwell Avenue
Suite 300
Lexington,  MA  02421
Correspondent Contact Kotei Aoki
Regulation Number876.1500
Classification Product Code
FED  
Date Received03/17/2023
Decision Date 09/15/2023
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
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