BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Coaptium Connect with Tissium Light

    K Number: K251957 · Decision Sep 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    75

    Basic Information

    Device Name
    Coaptium Connect with Tissium Light
    K Number
    K251957
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5270
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tissium SA
    Date Received
    June 25, 2025
    Decision Date
    September 8, 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
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    Other Clearances by Tissium SA

    K Number Device Name
    DEN240066 COAPTIUM Connect with TISSIUM LIGHT