FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L— 510(k) K243261

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K243261 for FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L, Substantially Equivalent on 2025-05-23. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2024-10-15
Decision date: 2025-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.