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510(k) Data Aggregation

    K Number
    K203081
    Device Name
    RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
    Manufacturer
    LSI Solutions
    Date Cleared
    2020-11-24

    (42 days)

    Product Code
    GAS, GAW
    Regulation Number
    878.5000
    Why did this record match?
    Product Code :

    GAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RAM® COR-SUTURE® QUICK LOAD® surgical suture is indicated for use in the approximation of soft tissue and prosthetic materials. The COR-SUTURE® OUICK LOAD® surgical suture is indicated for use in the approximation of soft tissue and prosthetic materials.
    Device Description
    LSI SOLUTIONS® offers both the RAM® COR-SUTURE® QUICK LOAD® surgical suture, which is a non-absorbable polytetrafluoroethylene (PTFE)-coated, braided polyester surgical suture, and the COR-SUTURE® QUICK LOAD® surgical suture, which is available as either a PTFE-coated, braided polyester surgical suture or a monofilament, uncoated polypropylene surgical suture. The RAM® COR-SUTURE® QUICK LOAD® surgical suture is also supplied with an optional pre-attached PTFE pledget that is used to aid in suture buttressing and to mechanically secure and support the suture in fragile tissue, increasing the suture holding strength. A short length of modified surgical stainless-steel tubing, called a "needle cap", is attached to each end of the suture for both the RAM® COR-SUTURE® QUICK LOAD® surgical suture and the COR-SUTURE® QUICK LOAD® surgical suture. Relative to the COR-SUTURE® QUICK LOAD® device, the RAM® COR-SUTURE® QUICK LOAD® device additionally includes a needle cap holder to secure the optional pledget and needle caps in the suture tray. Both the RAM® COR-SUTURE® QUICK LOAD® surgical suture and the COR-SUTURE® QUICK LOAD® surgical suture also include a detachable clear suture tube to keep the suture from tangling. The needle caps are removed from the sutures and discarded once suturing is completed as they are not intended for implantation in the patient; only the suture and pledget are implantable of components. Both devices are packaged for single patient use and are provided sterile by means of a validated ethylene oxide (EO) cycle. The polyester RAM® COR-SUTURE® QUICK LOAD® surgical suture is offered undyed (white), dyed green with the FDA approved colorant D&C Green No. 6. or striped green/white; all of which are offered with a surgical suture diameter of USP size 2-0 and a length of 38 inches. The polyester COR-SUTURE® QUICK LOAD® surgical suture is available undyed (white) or dyed green with the FDA approved colorant D&C Green No. 6 and will be offered with a surgical suture diameter of USP size 2-0 and a length of 38 inches. The polypropylene COR-SUTURE® QUICK LOAD® surgical suture is dyed blue with the FDA approved colorant [phthalocyaninato(2-)] copper and will be offered with a surgical suture diameter of USP size 3-0 and a length of 53 inches. For both polypropylene and polyester suture, there is no known significant change in tensile strength retention to occur in vivo. The RAM® COR-SUTURE® QUICK LOAD® and COR-SUTURE® QUICK LOAD® surgical sutures, with needle caps removed, contains implantable components which are considered MR safe. The implantable polyester and polypropylene sutures and PTFE pledget material are non-metallic and non-conducting materials and therefore, considered MR safe.
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    K Number
    K203120
    Device Name
    RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene
    Manufacturer
    LSI Solutions, Inc.
    Date Cleared
    2020-11-24

    (39 days)

    Product Code
    GAS, GAW
    Regulation Number
    878.5000
    Why did this record match?
    Product Code :

    GAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RD® QUICK LOAD® suture is intended for use in general soft tissue approximation and/or ligation.
    Device Description
    LSI SOLUTIONS® RD® QUICK LOAD® SUTURE is a non-absorbable surgical suture available as monofilament polypropylene suture (diameter of USP size 2-0) and polytetrafluoroethylene (PTFE)-coated, braided polyester suture (diameter of USP sizes 0 and 2-0). A short length of surgical stainless-steel tubing, called a "needle cap," is attached to one end of the suture. The needle cap is removed from the suture after suturing is completed and not meant for implantation into the patient. The RD® QUICK LOAD® SUTURE includes a detachable clear suture tube to keep the suture from tangling. The RD® QUICK LOAD® SUTURE is packaged for single patient use and is provided sterile by means of a validated ethylene oxide (EO) cycle. The polypropylene suture is dyed blue with the FDA approved colorant [phthalocyaninato(2-)] copper and will be offered with a surgical suture diameter of USP size 2-0 and in a length of 53 inches. The polyester suture is offered dyed green with the FDA approved colorant D&C Green No. 6 and is offered in a surgical suture diameter of USP size of 0 and 2-0 and a length of 53 inches. For both polypropylene and polyester suture, there is no known significant change in tensile strength retention to occur in vivo. The RD® QUICK LOAD® SUTURE products, with needle caps removed, contain implantable components which are considered MR (magnetic resonance) safe. The implantable polyester and polypropylene suture materials are non-metallic and nonconducting materials and therefore, considered MR safe.
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    K Number
    K091018
    Device Name
    ARTHREX BIOWIRE
    Manufacturer
    ARTHREX, INC.
    Date Cleared
    2010-07-30

    (477 days)

    Product Code
    GAS
    Regulation Number
    878.5000
    Why did this record match?
    Product Code :

    GAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002261
    Device Name
    MR-III
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    2000-10-23

    (90 days)

    Product Code
    GAS
    Regulation Number
    878.5000
    Why did this record match?
    Product Code :

    GAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MR-III is intended for use as a suture retention device to facilitate pecutaneous or endoscopic soft tissue repair. The indications for the MR-III are for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.
    Device Description
    The MR-III is a suture retention device manufactured from polyester suture, polyacetal bar, stainless steel needle and a plastic handle.
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    K Number
    K953128
    Device Name
    SUTURE CORD
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Date Cleared
    1996-02-09

    (218 days)

    Product Code
    GAS
    Regulation Number
    878.5000
    Why did this record match?
    Product Code :

    GAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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