AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR— 510(k) K132974

Name: FDA 510(k) clearance K132974
Creator: U.S. Food and Drug Administration
Published: 2013-12-03

Substantially Equivalent

Medtronic Advanced Energy, LLC

FDA 510(k) clearance K132974 for AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR, Substantially Equivalent on 2013-12-03. Applicant: Medtronic Advanced Energy, LLC. Device class: 2.

Clearance details

Applicant: Medtronic Advanced Energy, LLC
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2013-09-23
Decision date: 2013-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portsmouth, NH, 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.