FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5— 510(k) K183683

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K183683 for FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5, Substantially Equivalent on 2019-02-27. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code FDA
Advisory panel: Gastroenterology, Urology
Date received: 2018-12-28
Decision date: 2019-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDA

product code FDA

Death: 8
Injury: 148
Total: 156

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.