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510(k) Data Aggregation

    K Number
    K101378
    Device Name
    FRANKENMAN SURGICAL STAPLERS
    Date Cleared
    2010-06-29

    (43 days)

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

    SUZHOU FRANKENMAN MEDICAL EQUIPMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Frankenman Staplers are indicated as follows: Disposable Alimentary Canal Stapler: The Frankenman Disposable Alimentary Canal Stapler is used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic techniques. Single Use Circular Stapler for Rectal Prolapse and Hemorrhoid: The Frankenman Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids is a Circular Stapler product, with accessories, that has application for general surgical treatment of haemorrhoids and anorectal wall defects by means of transanal stapling and resection of mucosal and musculo-mucosal tissue resulting in occlusion of haemorrhoidal inflow, restoring the haemorrhoidal tissue to its normal physiological position. Disposable Reloadable Linear Stapler and Reloads: The Frankenman Disposable Reloadable Linear Stapler (and Reloads) is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. Disposable Reloadable Linear Cutter Stapler and Reloads: The Frankenman Disposable Reloadable Linear Cutter Stapler (and Reloads) has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.
    Device Description
    The Frankenman Staplers were designed in reference to the general principles of surgical staplers. Each stapler/ instrument is activated by squeezing the handle firmly as far as it will go. Specifics for each stapler include: - The Frankenman Disposable Alimentary Canal Stapler places a circular, double staggered row of titanium staples. Immediately after staple formation, the instrument's knife blade resects the excess tissue, creating a circular anastomosis. The diameter of the staple line is determined by the selection of the 21mm, 28mm, or 32mm stapler. - The Frankenman Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids places two circular peripheral lines of alternating and overlapping staples, thereby sealing off the rectal mucosa above the anal canal. The central circular cutting blade cuts the surplus tissue after the sealing to reconstruct the rectal mucosa. The diameter of the staple line is determined by the selection of the 32mm or 34mm stapler. - The Frankenman Disposable Reloadable Linear Stapler places a double(or triple in the case of the LS30-W) staggered row of titanium staples used for mechanical suturing and closure of tissue, prior to the removal of excess tissue. The Linear Stapler is available in 30mm, 45mm, 60mm, and 90mm line lengths for use in various applications. The instrument may be reloaded during a single procedure but cannot be reloaded more than seven times for a maximum of eight firings per instrument. - The Frankenman Disposable Reloadable Linear Cutter Stapler delivers two doubled staggered rows of titanium staples and anastomoses the internal tissues and incisions during surgical procedures. The Linear Cutter stapler is available in three staple line lengths (61mm, 81mm, or 101mm). The instrument may be reloaded during a single procedure but cannot be reloaded more than seven times for a maximum of eight firings per instrument. The use of the instrument with staple buttressing materials, or across a previous staple line, may reduce the number of firings.
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