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510(k) Data Aggregation

    K Number
    K241376
    Device Name
    HyperSuture All Blue Extension Line
    Manufacturer
    Threadstone L.L.C.
    Date Cleared
    2024-08-09

    (86 days)

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

    Threadstone L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HyperSuture All Blue Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.
    Device Description
    HyperSuture All Blue 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. HyperSuture All Blue Extension Line cables are available in USP 2 and USP 5 and meet all surgical suture requirements established by the USP for class II non-absorbable surgical sutures. HyperSuture All Blue Extension Line tapes are non-absorbable, sterile, surgical braids, composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture tape sizes do not conform to USP diameter requirements; however, HyperSuture tapes meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures. HyperSuture tape sizes are available in 1.5mm tape (USP 2 equivalent) and 2.0mm tape (USP 5 equivalent). Both HyperSuture All Blue Extension Line cables and tapes are available in blue, 36 inches in length, and with or without pre-attached needles.
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    K Number
    K234079
    Device Name
    HyperSuture Extension Line
    Manufacturer
    Threadstone L.L.C.
    Date Cleared
    2024-05-10

    (140 days)

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

    Threadstone L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HyperSuture Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.
    Device Description
    HyperSuture 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 Extension Line cables are available in USP 2 and USP 5 and tapes are available in 1.5 (USP 2 equivalent) and 2.5 (USP 5 equivalent). Both HyperSuture Extension Line cables and tapes are available in white/blue, 40 inches in length, and with or without pre-attached AISI 302 stainless steel needles.
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    K Number
    K230311
    Device Name
    HyperSuture
    Manufacturer
    Threadstone L.L.C.
    Date Cleared
    2023-11-24

    (294 days)

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

    Threadstone L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HyperSutures (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation. including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.
    Device Description
    HyperSuture 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. HyperSuture cables are available in USP 2-0, USP 2, and USP 5 and meet all surqical suture requirements established by the USP for class II non- absorbable surgical sutures. HyperSuture tapes are non-absorbable, sterile, braid for surgery composed of multiple multifilament strands of ultra-high molecular weight polvethylene (UHMWPE) braided together to form the implant. HyperSuture tape sizes do not conform to USP diameter requirements; however, HyperSuture tapes meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures. HyperSuture tape sizes are available in Threadstone tape size 0.5 (USP 2-0 equivalent), tape 1.5 (USP 2 equivalent), and tape 2.5 (USP 5 equivalent). Both HyperSuture cables and tapes are available in white/black, 40 inches in length, and with or without pre-attached needles.
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