K251653
- 510(k) number
- K251653
- Device name
- SPRY TMS Therapy System (0550)
- Applicant
- Soterix Medical, Inc. NJ · US
- Product code
- OBP — Transcranial Magnetic Stimulator
- Decision date
- 2026-02-20
- Date received
- 2025-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251653.pdf
Official FDA record: K251653
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.