EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS— 510(k) K031081

Substantially Equivalent

Gyrus Medical, Inc.

FDA 510(k) clearance K031081 for EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS, Substantially Equivalent on 2003-05-21. Applicant: Gyrus Medical, Inc..

Clearance details

Applicant: Gyrus Medical, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2003-04-04
Decision date: 2003-05-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, 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.