FDA.report

510(k) K233321

Device
Double Balloon Endoscope EN-840T, Over-tube TS-1214C
Applicant
FUJIFILM Healthcare Americas Corporation
510(k) number
K233321
Product code
FDA
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-13
Date received
2023-09-29
Regulation
876.1500
Classification name
Enteroscope And Accessories
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Chaitrali Kulkarni
Address
81 Hartwell Ave. Suite 300 Lexington MA US 02421 02421

FDA Registration Numbers

Source Documents

510(k) summary PDF

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