BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    Suture-TOOL System

    K Number: K250977 · Decision Apr 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    Suture-TOOL System
    K Number
    K250977
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suturion AB
    Date Received
    March 31, 2025
    Decision Date
    April 28, 2025
    Product Code
    NEW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NEW Suture, Surgical, Absorbable, Polydioxanone

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    Other Clearances by Suturion AB

    K Number Device Name
    K242835 Suture-TOOL System