SPRY TMS Therapy System (0550)— 510(k) K251653
Substantially EquivalentSoterix Medical, Inc.
FDA 510(k) clearance K251653 for SPRY TMS Therapy System (0550), Substantially Equivalent on 2026-02-20. Applicant: Soterix Medical, Inc.. Device class: 2.
Summary
Soterix Medical's SPRY TMS Therapy System (0550) is filed under product code OBP, transcranial magnetic stimulator. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 882.5805. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Soterix Medical filed from Woodbridge, New Jersey. The substantially equivalent decision came 267 calendar days after receipt (May 29, 2025 to February 20, 2026).
Clearance details
- Applicant
- Soterix Medical, Inc.
- Product code
- Product code OBP
- Device class
- Class 2
- Regulation
- 21 CFR 882.5805
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woodbridge, NJ, US
Recent devices under product code OBP
view allMore clearances from Soterix Medical, Inc.
view allAdverse events under product code OBP
product code OBP- Injury
- 270
- Total
- 270
Source: openFDA MAUDE database, through . 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.