FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5— 510(k) K042076

Substantially Equivalent

Fujinon, Inc.

FDA 510(k) clearance K042076 for FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5, Substantially Equivalent on 2004-11-18. Applicant: Fujinon, Inc..

Clearance details

Applicant: Fujinon, Inc.
Product code: Code FDT
Advisory panel: Gastroenterology, Urology
Date received: 2004-08-02
Decision date: 2004-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntington, CT, US

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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.