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510(k) Data Aggregation

    K Number
    K242201
    Device Name
    HyperSuture White/Green Extension Line
    Manufacturer
    Threadstone LLC
    Date Cleared
    2025-03-27

    (244 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Threadstone LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HyperSuture™ White/Green Extension Line 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
    HyperSuture™ White/Green Extension Line cables are non-absorbable, sterile, surgical sutures composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. The sutures are intended to be used for general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and allograft tissues for orthopedic procedures. HyperSuture™ White/Green Extension Line cables are available in USP #2-0. USP #2. and USP #5 and tapes are available in 0.8mm (USP 2-0 equivalent), 1.5mm (USP 2 equivalent) and 2.0mm (USP 5 equivalent). Both HyperSuture™ White/Green Extension Line cables and tapes are available in white/green, 36 inches or 40 inches in length, and with or without pre-attached AISI 302 stainless steel needles.
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