ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC— 510(k) K082834

Substantially Equivalent

Ellman Int'L, Inc.

FDA 510(k) clearance K082834 for ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC, Substantially Equivalent on 2009-05-07. Applicant: Ellman Int'L, Inc..

Clearance details

Applicant: Ellman Int'L, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2008-09-26
Decision date: 2009-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oceanside, NY, 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.