E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE— 510(k) K060255

Substantially Equivalent

E Surgical, LLC

FDA 510(k) clearance K060255 for E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE, Substantially Equivalent on 2006-03-31. Applicant: E Surgical, LLC.

Clearance details

Applicant: E Surgical, LLC
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2006-02-01
Decision date: 2006-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, 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.