GENII GI 4000 ELECTROSUGICAL GENERATOR— 510(k) K113265

Substantially Equivalent

Genii, Inc.

FDA 510(k) clearance K113265 for GENII GI 4000 ELECTROSUGICAL GENERATOR, Substantially Equivalent on 2012-03-22. Applicant: Genii, Inc..

Clearance details

Applicant: Genii, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2011-11-04
Decision date: 2012-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.