STEELEX ELECTRODE SET— 510(k) K030556

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K030556 for STEELEX ELECTRODE SET, Substantially Equivalent on 2003-04-22. Applicant: Aesculap, Inc..

Clearance details

Applicant: Aesculap, Inc.
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 2003-02-21
Decision date: 2003-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

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Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

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.