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510(k) Data Aggregation

    K Number
    K023372
    Device Name
    NON-BIOABSORBABLE STAPLE
    Manufacturer
    ONUX MEDICAL, INC.
    Date Cleared
    2002-12-27

    (80 days)

    Product Code
    NJU
    Regulation Number
    878.4495
    Why did this record match?
    Product Code :

    NJU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coil Fixation Device is intended for fixation of prosthetic material and approximation of tissue in endoscopic and open surgical procedures.
    Device Description
    The subject device is designed to deliver fixation springs via a minimally invasive sterile disposable instrument that is for single patient use. The fixation springs are made of nitinol and are composed of 3 coils that are approximately .18 inches in diameter. The spring is held within the lumen of a needle is inserted through the tissue or prosthetic material to be approximated or fixated and the spring is pushed out so that approximately 1 coil of the spring is released. The needle is then withdrawn from the tissue or prosthetic material while the remainder of the spring is pushed out thereby deploying at least one coil on the proximal surface of the tissue or prosthetic material. Because the spring is manufactured such that the coils are naturally pre-compressed against each other, the distal and proximal coils place a compression force on the tissue or prosthetic material that holds them together.
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    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?
    Product Code :

    NJU

    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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