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

    HyperSuture

    K Number: K230311 · Decision Nov 24, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    242
    Same Product Code
    173
    Applicant Total
    5
    Review Days
    294

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    Basic Information

    Device Name
    HyperSuture
    K Number
    K230311
    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
    February 3, 2023
    Decision Date
    November 24, 2023
    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
    K254275 HyperSuture All Green Extension Line
    K242201 HyperSuture White/Green Extension Line
    K241376 HyperSuture All Blue Extension Line
    K234079 HyperSuture Extension Line