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510(k) Data Aggregation

    K Number
    K101444
    Device Name
    AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY
    Manufacturer
    SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO
    Date Cleared
    2010-06-14

    (21 days)

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

    SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Autosuture™ Endo GIA™ Staplers with Endo GIA™ Single Use Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection. transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
    Device Description
    The Endo GIA™ Single Use Tan Reload with Tri-Staple™ Technology when used with the Endo GIA™ Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. For the Tan reload, the staple sizes are 2.0, 2.5, and 3.0 mm for use in vascular and medium thick tissue. The Tan Reloads are available in 30mm. 45mm and 60mm staple line lengths as well as curved-tip anvil configurations. Tri-Staple™ Technology means that each of the two triple-staggered rows has a stepped configuration whereby the staples in the outer row are a taller height than the staples in the middle row which in turn are a taller height than the staples in the inner row. The size of the staples is determined by the selection of the appropriate single use Reload.
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    K Number
    K093402
    Device Name
    AUTOSUTURE EEA ORVIL
    Manufacturer
    SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO
    Date Cleared
    2009-11-12

    (10 days)

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

    SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DST Series ™ EEA™ OrVil™ 21 mm device when used with the DST Series™ EEA™ 21 mm stapler, the DST Series ™ EEA™ OrViJ™ 25 mm device when used with the DST Series™ EEA™ 25mm stapler, and the DST Series ™ EEA™ OrVil™ 28 mm device when used with the DST Series ™EEA™ 28 mm stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
    Device Description
    The DST Series™ EEA™ 21, 25 or 28 mm stapler, creates a circular, double staggered row of titanium staples. Immediately after staple formation, the stapler knife blade resects the excess tissue, creating a circular anastomosis. The DST Series™ EEA Surgical Stapler comes with a detachable anvil. As an accessory to this instrument we have modified the detachable anvil assembly to create the DST Series OrVil™. The anvil assembly is mounted on a delivery tube and is secured to the tube. A retraction suture is also tied to the anvil assembly.
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