FUJIFILM Endoscope Models EC-600HL and EC-600LS— 510(k) K180405

Name: FDA 510(k) clearance K180405
Creator: U.S. Food and Drug Administration
Published: 2018-03-15

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K180405 for FUJIFILM Endoscope Models EC-600HL and EC-600LS, Substantially Equivalent on 2018-03-15. Applicant: Fujifilm Corporation. Device class: 2.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code FDF
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2018-02-14
Decision date: 2018-03-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.