HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE— 510(k) K024138

Substantially Equivalent

Olympus Optical Co., Ltd.

FDA 510(k) clearance K024138 for HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE, Substantially Equivalent on 2003-03-12. Applicant: Olympus Optical Co., Ltd..

Clearance details

Applicant: Olympus Optical Co., Ltd.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2002-12-16
Decision date: 2003-03-12
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.