MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES— 510(k) K113597

Name: FDA 510(k) clearance K113597
Creator: U.S. Food and Drug Administration
Published: 2012-06-03

Substantially Equivalent

Minilap Technologies

FDA 510(k) clearance K113597 for MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES, Substantially Equivalent on 2012-06-03. Applicant: Minilap Technologies. Device class: 2.

Clearance details

Applicant: Minilap Technologies
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2011-12-05
Decision date: 2012-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dobbs Ferry, NY, US

Download summary PDF View on FDA.gov ↗

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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.