FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5— 510(k) K041903

Substantially Equivalent

Fujinon, Inc.

FDA 510(k) clearance K041903 for FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5, Substantially Equivalent on 2004-11-10. Applicant: Fujinon, Inc..

Clearance details

Applicant: Fujinon, Inc.
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2004-07-14
Decision date: 2004-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, US

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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.