Neuroblade System— 510(k) K230125

Substantially Equivalent

Clearmind Biomedical

FDA 510(k) clearance K230125 for Neuroblade System, Substantially Equivalent on 2023-10-13. Applicant: Clearmind Biomedical.

Clearance details

Applicant: Clearmind Biomedical
Product code: Code GWG
Advisory panel: Neurology
Date received: 2023-01-17
Decision date: 2023-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.