Endoscope Model EG-580UT and Endoscope Model EG-580UR— 510(k) K221952

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K221952 for Endoscope Model EG-580UT and Endoscope Model EG-580UR, Substantially Equivalent on 2022-08-04. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code ODG
Advisory panel: Gastroenterology, Urology
Date received: 2022-07-05
Decision date: 2022-08-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODG

product code ODG

Death: 30
Injury: 237
Malfunction: 12,387
Other: 1
Total: 12,655

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.