FUJIFILM Duodenoscope Model— 510(k) K182051

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K182051 for FUJIFILM Duodenoscope Model, Substantially Equivalent on 2018-10-02. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code FDT
Advisory panel: Gastroenterology, Urology
Date received: 2018-07-31
Decision date: 2018-10-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDT

product code FDT

Death: 86
Injury: 1,954
Malfunction: 14,912
Total: 16,952

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.