OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES— 510(k) K981219

Substantially Equivalent

Enable Medical Corp.

FDA 510(k) clearance K981219 for OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES, Substantially Equivalent on 1998-06-29. Applicant: Enable Medical Corp..

Clearance details

Applicant: Enable Medical Corp.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1998-04-03
Decision date: 1998-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, OH, 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.