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510(k) Data Aggregation

    K Number
    K100257
    Device Name
    VLOC9ABSORBABLE WOUND CLOSURE DEVICE
    Manufacturer
    SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE
    Date Cleared
    2010-05-10

    (102 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    V-Loc™ 90 Absorbable Wound Closure Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
    Device Description
    The V-Loc™ 90 Absorbable Wound Closure Device is a suture prepared from a synthetic polyester (Glycomer™ 631) composed of glycolide, dioxanone and trimethylene carbonate. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc™ 90 Absorbable Wound Closure Device will be offered both Undyed (clear) and Dyed with D&C Violet No. 2 at a level not exceeding 0.2% by weight of the suture in sizes U.S.P. (EP) 4-0 (Metric 2.0) 3-0 (Metric 3), 2-0 (Metric 3.5) and 0 (Metric 4). They will be supplied in pre-cut lengths affixed to various needle types.
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    K Number
    K100242
    Device Name
    AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER
    Manufacturer
    SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE
    Date Cleared
    2010-02-17

    (21 days)

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

    SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic marking.
    Device Description
    The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier contains 16 titanium clips. The applier is designed for introduction and use through an appropriately sized trocar sleeve, or larger with the use of a converter. The ENDO CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft rotation knob, clip counter window and a 33 cm shaft with jaws at its distal end. Squeezing the handle places a titanium clip in the jaws and closes the jaws to close the clip on the vessel or structure.
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    K Number
    K093408
    Device Name
    V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
    Manufacturer
    SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE
    Date Cleared
    2009-11-12

    (10 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    V-Loc™ 180 absorbable wound closure devices are indicated for soft tissue approximation where use of an absorbable suture is appropriate.
    Device Description
    The V-Loc™ 180 absorbable wound closure device (Size 4-0) is prepared from a copolymer of glycolic acid and trimethylene carbonate. The absorbable wound closure device is available clear or green. The device is sterile, inert, noncollagenous and nonantigenic.
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