FUJIFILM Endoscope Model EG-530N— 510(k) K183686

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K183686 for FUJIFILM Endoscope Model EG-530N, Substantially Equivalent on 2019-02-28. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 2018-12-28
Decision date: 2019-02-28
Decision: Substantially Equivalent
Clearance type: Special
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.