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510(k) Data Aggregation

    K Number
    K254275

    Validate with FDA (Live)

    Device Name
    HyperSuture All Green Extension Line
    Manufacturer
    Threadstone, LLC
    Date Cleared
    2026-03-23

    (83 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K230311,K242201
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K230311, K242201

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HyperSuture™ All Green Extension sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.

    Device Description

    The Threadstone HyperSuture All Green Extension cables, loops, and tapes are nonabsorbable, sterile, surgical sutures composed of multiple multifilament strands of ultrahigh molecular weight polyethylene (UHMWPE) braided together to form the implant.

    HyperSuture All Green Extension cables and tapes are available in 36 inches and 40 inches in length. The loop configurations are available in 24" or 2" loop configurations. HyperSuture All Green Extension cable, loops, and tape sizes include USP #2-0, USP #0, USP #1, USP #2, USP #3, USP #5, and 1.0mm tape, 1.2mm tape, 1.5mm tape, 1.8mm tape, 2.0mm tape. All variations of the suture, cables, loops, and tapes, are available with or without pre-attached needles.

    AI/ML Overview

    N/A

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