OLYMPUS BF TYPE UC160-OL8— 510(k) K042140

Substantially Equivalent

Olympus Corporation

FDA 510(k) clearance K042140 for OLYMPUS BF TYPE UC160-OL8, Substantially Equivalent on 2004-08-18. Applicant: Olympus Corporation.

Clearance details

Applicant: Olympus Corporation
Product code: Code ODG
Advisory panel: Gastroenterology, Urology
Date received: 2004-08-09
Decision date: 2004-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

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Adverse events under product code ODG

product code ODG

Death: 30
Injury: 237
Malfunction: 12,387
Other: 1
Total: 12,655

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.