GF-UE160-AL5 ULTRASOUND ENDOSCOPE— 510(k) K051541

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K051541 for GF-UE160-AL5 ULTRASOUND ENDOSCOPE, Substantially Equivalent on 2005-07-01. Applicant: Olympus America, Inc..

Clearance details

Applicant: Olympus America, Inc.
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2005-06-10
Decision date: 2005-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, 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.