OLYMPUS ULTRASONIC SURGICAL SYSTEM— 510(k) K031523

Substantially Equivalent

Aomori Olympus Co., Ltd.

FDA 510(k) clearance K031523 for OLYMPUS ULTRASONIC SURGICAL SYSTEM, Substantially Equivalent on 2003-10-01. Applicant: Aomori Olympus Co., Ltd..

Clearance details

Applicant: Aomori Olympus Co., Ltd.
Product code: Code LFL
Advisory panel: Unknown
Date received: 2003-05-15
Decision date: 2003-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

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Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.