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

    HyperSuture All Green Extension Line

    K Number: K254275 · Decision Mar 23, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    242
    Same Product Code
    173
    Applicant Total
    5
    Review Days
    83

    Basic Information

    Device Name
    HyperSuture All Green Extension Line
    K Number
    K254275
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Threadstone, LLC
    Date Received
    December 30, 2025
    Decision Date
    March 23, 2026
    Product Code
    GAT
    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
    GAT Suture, Nonabsorbable, Synthetic, Polyethylene

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    Other Clearances by Threadstone, LLC

    K Number Device Name
    K242201 HyperSuture White/Green Extension Line
    K241376 HyperSuture All Blue Extension Line
    K234079 HyperSuture Extension Line
    K230311 HyperSuture