510(k) K261833— NEUROMARK System (NMK00301)

Substantially Equivalent

Neurent Medical , Ltd.

Clearance details

Applicant: Neurent Medical , Ltd.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2026-06-02
Decision date: 2026-06-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Galway, IE

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.