FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01— 510(k) K223827

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K223827 for FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01, Substantially Equivalent on 2023-09-08. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2022-12-21
Decision date: 2023-09-08
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.