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510(k) Data Aggregation

    K Number
    K173917
    Device Name
    neoClose PDS
    Manufacturer
    Date Cleared
    2018-11-08

    (321 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    neoSurgical Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    neoClose® PDS is indicated for the approximation of soft tissue or prosthetic material during open or laparoscopic surgical procedures.
    Device Description
    The neoClose PDS device consists of absorbable PDS Anchors and neoClose Drivers. The PDS Anchor consists of an absorbable PDS suture attached to an absorbable polymeric anchor. There are two distinct product codes: the neoClose PDS Anchor x 2 (NCPDSX2-U) and the neoClose PDS Anchor x 4 (NCPDSX4-U). The neoClose PDS Anchors and Drivers are provided sterile (EtO). The neoClose PDS Anchors are pre-loaded on neoClose Drivers, which are passed through soft tissue for subsequent soft tissue or prosthetic material approximation.
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    K Number
    K142903
    Device Name
    neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US
    Manufacturer
    Date Cleared
    2014-11-12

    (37 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOSURGICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    neoClose is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/laparoscopic surgery.
    Device Description
    The neoClose AutoAnchor Pack consists of absorbable AutoAnchors and neoClose Drivers. The neoClose AutoAnchor consists of an absorbable suture attached to an absorbable polymeric anchor. There are two distinct product codes: the neoClose 2 AutoAnchor Pack (NCAA2-U) and the neoClose 4 AutoAnchor Pack (NCAA4-U). The neoClose AutoAnchors and Drivers are provided sterile (EtO). Each neoClose AutoAnchor is pre-loaded on a neoClose Driver. The neoClose Driver is used to deliver an AutoAnchor through the abdominal wall layers into the abdominal cavity for subsequent soft tissue approximation. The neoClose AutoAnchor and Driver are to be used in conjunction with a neoClose Guide.
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    K Number
    K131688
    Device Name
    NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
    Manufacturer
    Date Cleared
    2013-07-18

    (38 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOSURGICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery.
    Device Description
    The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery. There are two neoClose product codes, neoClose Hasson and neoClose Universal, each consisting of an AccuGuide and two AutoAnchors loaded onto two Drivers. The neoClose Hasson is designed to provide sealed anchoring of a laparoscopic trocar and suture placement for subsequent soft tissue approximation. The neoClose Universal is equivalent to the neoClose Hasson design in its method of soft tissue approximation but does not provide for sealed anchoring of a trocar. Soft tissue approximation is facilitated by delivering two AutoAnchors, through an AccuGuide with a Driver. The AutoAnchors and Drivers for both the neoClose Hasson and Universal are identical but the AccuGuides differ in construction. The Hasson AccuGuide features Suture Locks, a flexible Sleeve, and two Guide Channels while the Universal AccuGuide features a Thumb Grip and one Guide Channel.
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    K Number
    K123280
    Device Name
    NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
    Manufacturer
    Date Cleared
    2013-04-18

    (178 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOSURGICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery.
    Device Description
    The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic surgery. There are two neoClose product codes, neoClose Hasson and neoClose Universal, each consisting of an AccuGuide and two AutoAnchors loaded onto two Drivers. The neoClose Hasson is designed to provide sealed anchoring of a laparoscopic trocar and suture placement for subsequent soft tissue approximation. The neoClose Universal is equivalent to the neoClose Hasson design in its method of soft tissue approximation but does not provide for sealed anchoring of a trocar. Soft tissue approximation is facilitated by delivering two AutoAnchors, through an AccuGuide with a Driver. The AutoAnchors and Drivers for both the neoClose Hasson and Universal are identical but the AccuGuides differ in construction. The Hasson AccuGuide features Suture Locks, a flexible Sleeve, and two Guide Channels while the Universal AccuGuide features a Thumb Grip and one Guide Channel.
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