AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER— 510(k) K123201

Substantially Equivalent

Medtronic Advanced Energy, LLC

FDA 510(k) clearance K123201 for AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER, Substantially Equivalent on 2013-01-10. Applicant: Medtronic Advanced Energy, LLC.

Clearance details

Applicant: Medtronic Advanced Energy, LLC
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2012-10-12
Decision date: 2013-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portsmouth, NH, 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.