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

Name: FDA 510(k) clearance K981219
Creator: U.S. Food and Drug Administration
Published: 1998-06-29

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.. Device class: 2.

Clearance details

Applicant: Enable Medical Corp.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
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

Download summary PDF View on FDA.gov ↗

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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.