PSD-60/ENDOPLASMA— 510(k) K042274

Substantially Equivalent

Olympus Shirakawa Co., Ltd.

FDA 510(k) clearance K042274 for PSD-60/ENDOPLASMA, Substantially Equivalent on 2005-02-22. Applicant: Olympus Shirakawa Co., Ltd..

Clearance details

Applicant: Olympus Shirakawa Co., Ltd.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2004-08-23
Decision date: 2005-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.