FUJIFILM Endoscope Model EI-740D/S— 510(k) K221551

Substantially Equivalent

Fujifilm Corporaton

FDA 510(k) clearance K221551 for FUJIFILM Endoscope Model EI-740D/S, Substantially Equivalent on 2023-01-27. Applicant: Fujifilm Corporaton.

Clearance details

Applicant: Fujifilm Corporaton
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2022-05-31
Decision date: 2023-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

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.