SPRY TMS Therapy System (0550)— 510(k) K251653

Substantially Equivalent

Soterix Medical, Inc.

FDA 510(k) clearance K251653 for SPRY TMS Therapy System (0550), Substantially Equivalent on 2026-02-20. Applicant: Soterix Medical, Inc..

Clearance details

Applicant: Soterix Medical, Inc.
Product code: Code OBP
Advisory panel: Neurology
Date received: 2025-05-29
Decision date: 2026-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodbridge, NJ, 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.