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510(k) Data Aggregation

    K Number
    K091016
    Device Name
    COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE
    Date Cleared
    2009-05-04

    (25 days)

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

    SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is intended for use for approximation of soft tissue such as the repair of meniscal tear infuries
    Device Description
    The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is a sterile single use device for the approximation of soft tissue such as the repair of meniscal tears. The disposable single use Device is comprised of a suture-passing needle mechanism which is pre-loaded with Size 2/0 Force Fiber Ultra High Molecular Weight (UHMW) Non Absorbable Polyethylene suture (K040472), inclusive of a pre-tied knot. The distal end of the device will be offered in various angular configurations to enable access to areas of the meniscal anatomy, and to allow for user preference.
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    K Number
    K083781
    Device Name
    EEA HEMORRHOID STAPLER & ACCESSORIES
    Date Cleared
    2009-02-04

    (47 days)

    Product Code
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EEA™ Hemorrhoid Stapler and accessories has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The EEA™ Hemorrhoid Stapler and accessories can also be used in the lower alimentary tract for the creation of end-to-end and end-to-side anastomosis.
    Device Description
    The EEA™ Hemorrhoid stapler is designed for use as a stapling instrument for control of hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST™ staples. The EEA™ Hemorrhoid Stapler is offered in a 33mm diameter and with 3.5mm and 4.8mm staple sizes. The accompanying accessories are comprised of a purse-string suture Anoscope, a Port, and a Dilator.
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    K Number
    K082535
    Device Name
    COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE
    Date Cleared
    2008-12-01

    (90 days)

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

    SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Covidien Sports Surgery AS Meniscal Repair Device is Intended for use for approximation of soft tissue such as the repair of meniscal tear injuries
    Device Description
    The Covidien Sports Surgery AS Meniscal Repair Device is a sterile single use device for the approximation of soft tissue such as for the repair of meniscal tears. The disposable single use Device is comprised of a suture-passing needle mechanism which is pre-loaded with a strand of Size 2/0 nonabsorbable polyethylene terephthalate surgical suture (TiCron™) which includes a pre-tied knot.
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