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510(k) Data Aggregation

    K Number
    K040821
    Device Name
    COALESCENT SURGICAL U-CLIP AND ACCESSORIES
    Manufacturer
    COALESCENT SURGICAL
    Date Cleared
    2004-04-23

    (24 days)

    Product Code
    FZP, NJU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    COALESCENT SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coalescent Surgical PG-CLIP™ and accessories are intended for endoscopic and non-endoscopic peripheral vascular and general surgical soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in peripheral vascular blood vessels, grafts and other tubular structures. The PG-CLIP is not intended for use in cardiac and/or thoracic procedures; including, but not limited to intra-cardiac and coronary artery bypass grafting (CABG) procedures.
    Device Description
    The Coalescent Surgical PG-CLIP™ device is a self-closing clip for peripheral vascular anastomosis and tissue approximation/attachment applications. The PG-CLIP consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may or may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel cutting and retention tools.
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    K Number
    K031623
    Device Name
    MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
    Manufacturer
    COALESCENT SURGICAL
    Date Cleared
    2003-07-03

    (41 days)

    Product Code
    FZP, NCA, NJU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    COALESCENT SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
    Device Description
    The Coalescent Surgical U-CLIP™ device is a self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel cutting and retention tools.
    Ask a Question
    K Number
    K024366
    Device Name
    COALESCENT SURGICAL U-CLIP AND ACCESSORIES
    Manufacturer
    COALESCENT SURGICAL
    Date Cleared
    2003-01-17

    (17 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    COALESCENT SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
    Device Description
    The Coalescent Surgical U-CLIP™ device is a self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel retention tools.
    Ask a Question
    K Number
    K023125
    Device Name
    COALESCENT U-CLIP- AND ACCESSORIES
    Manufacturer
    COALESCENT SURGICAL
    Date Cleared
    2002-12-18

    (90 days)

    Product Code
    NJU
    Regulation Number
    878.4495
    Why did this record match?
    Applicant Name (Manufacturer) :

    COALESCENT SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coalescent Surgical U-CLIP™ and accessories is indicated for use in general soft tissue approximation and /or ligation, including use in cardiovascular procedures.
    Device Description
    The Coalescent Surgical U-CLIP™ device is a single self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of a specially designed vascular clip (optionally containing suture) and connected to needles via flexible members (optionally including various types of suture). This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip removal devices and vessel retention tools.
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    K Number
    K021407
    Device Name
    COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES
    Manufacturer
    COALESCENT SURGICAL
    Date Cleared
    2002-07-03

    (61 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    COALESCENT SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The modified Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic tissue and prosthetic material approximation/attachment and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
    Device Description
    The modified Coalescent Surgical U-CLIP™ is a single self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of a specially designed vascular clip connected to needles via flexible members. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip removal devices and vessel retention tools.
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    K Number
    K013664
    Device Name
    COALESCENT SURGICAL U-CLIP
    Manufacturer
    COALESCENT SURGICAL
    Date Cleared
    2002-01-24

    (79 days)

    Product Code
    NCA
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    COALESCENT SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic use in tissue and prosthetic material approximation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including cardiovascular and coronary artery bypass grafting procedures.
    Device Description
    The Coalescent Surgical U-CLIP™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The U-CLIP consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure and facilitation of an interrupted technique. The device is fabricated from standard medical and implantable grade materials.
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    K Number
    K012317
    Device Name
    COALESCENT SURGICAL U-CLIP
    Manufacturer
    COALESCENT SURGICAL
    Date Cleared
    2001-08-31

    (39 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    COALESCENT SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coalescent Surgical U-Clip™ is intended for endoscopic and non-endoscopic use in tissue and prosthetic material approximation and the creation of anastomoses in blood vessels, grafts and other tubular structures.
    Device Description
    The Coalescent Surgical U-Clip™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The U-Clip consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.
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    K Number
    K003958
    Device Name
    COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE
    Manufacturer
    COALESCENT SURGICAL
    Date Cleared
    2001-02-06

    (47 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    COALESCENT SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994160
    Device Name
    COALESCENT SURGICAL SUTURED-CLIP
    Manufacturer
    COALESCENT SURGICAL
    Date Cleared
    2000-02-04

    (57 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    COALESCENT SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coalescent Surgical Sutured-Clip™ is intended for endoscopic and non-endoscopic use in the creation of anastomoses in blood vessels, grafts and other tubular structures.
    Device Description
    The Coalescent Surgical Sutured-Clip™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The Sutured-Clip consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.
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