SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF— 510(k) K013255

Substantially Equivalent

Ellman Intl., Inc.

FDA 510(k) clearance K013255 for SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF, Substantially Equivalent on 2001-11-07. Applicant: Ellman Intl., Inc..

Clearance details

Applicant: Ellman Intl., Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2001-09-28
Decision date: 2001-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hewlett, NY, US

Download summary PDF View on FDA.gov ↗

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.