FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R— 510(k) K243260

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K243260 for FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R, Substantially Equivalent on 2025-04-11. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 2024-10-15
Decision date: 2025-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.