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

    allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)

    K Number: K252051 · Decision Sep 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    90

    Basic Information

    Device Name
    allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)
    K Number
    K252051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5260
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tulavi Therapeutics, Inc.
    Date Received
    July 1, 2025
    Decision Date
    September 29, 2025
    Product Code
    SBG
    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
    SBG In Situ Polymerizing Peripheral Nerve Cap

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (SBG), ordered by most recent decision date.

    allay Nerve Cap

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