FUJIFILM Endoscope Model EB-710P— 510(k) K220957

Name: FDA 510(k) clearance K220957
Creator: U.S. Food and Drug Administration
Published: 2022-11-10

Substantially Equivalent

Fujifilm Corporaton

FDA 510(k) clearance K220957 for FUJIFILM Endoscope Model EB-710P, Substantially Equivalent on 2022-11-10. Applicant: Fujifilm Corporaton. Device class: 2.

Clearance details

Applicant: Fujifilm Corporaton
Product code: Code EOQ
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 2022-04-01
Decision date: 2022-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.