BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SPRY TMS Therapy System (0550)

    K Number: K251653 · Decision Feb 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    65
    Applicant Total
    6
    Review Days
    267

    Basic Information

    Device Name
    SPRY TMS Therapy System (0550)
    K Number
    K251653
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5805
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Soterix Medical, Inc.
    Date Received
    May 29, 2025
    Decision Date
    February 20, 2026
    Product Code
    OBP
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OBP Transcranial Magnetic Stimulator

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    Other Clearances by Soterix Medical, Inc.

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