NeuroStar Advanced Therapy System (All previously cleared models)— 510(k) K231926

Substantially Equivalent

Neuronetics, Inc.

FDA 510(k) clearance K231926 for NeuroStar Advanced Therapy System (All previously cleared models), Substantially Equivalent on 2024-03-22. Applicant: Neuronetics, Inc..

Clearance details

Applicant: Neuronetics, Inc.
Product code: Code OBP
Advisory panel: Neurology
Date received: 2023-06-30
Decision date: 2024-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

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.