FDA.report

510(k) K251861

Device
FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
Applicant
Fujifilm Corporation
510(k) number
K251861
Product code
FDT
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-09
Date received
2025-06-17
Regulation
876.1500
Classification name
Duodenoscope And Accessories, Flexible/Rigid
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Chaitrali Kulkarni
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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