FDA.report

510(k) K223295

Device
Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
Applicant
Fujifilm Corporaton
510(k) number
K223295
Product code
FDA
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-11
Date received
2022-10-26
Regulation
876.1500
Classification name
Enteroscope And Accessories
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Randy Vader
Address
798 Miyanodai Kaisei-Machi Ashigara Kami-Gun JP 258-8538 258-8538

FDA Registration Numbers

Source Documents

510(k) summary PDF

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