BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇫🇷 France

    COAPTIUM Connect with TISSIUM LIGHT

    K Number: DEN240066 · Decision Jun 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    208

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    Basic Information

    Device Name
    COAPTIUM Connect with TISSIUM LIGHT
    K Number
    DEN240066
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.5270
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Tissium SA
    Date Received
    November 21, 2024
    Decision Date
    June 17, 2025
    Product Code
    SFD
    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
    SFD In Situ Polymerizing Peripheral Nerve Repair Device

    Similar 510(k) Clearances

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

    Coaptium Connect with Tissium Light

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Tissium SA

    K Number Device Name
    K251957 Coaptium Connect with Tissium Light