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510(k) Data Aggregation

    K Number
    K103470
    Device Name
    PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP
    Manufacturer
    B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD
    Date Cleared
    2011-01-11

    (46 days)

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

    B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PANTHER Circular The Panther Circular staplers and accessories have application Stapler throughout the alimentary tract to create end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. PANTHER The PANTHER Hemorrhoidal Circular Stapler and accessories Hemorrhoidal have application throughout the anal to perform surgical Circular Stapler treatment of hemorrhoidal disease. PANTHER Linear The PANTHER Linear Stapler can be applied in abdominal, Stapler thoracic and pediatric surgical procedures for transection or resection of tissue. PANTHER Linear The PANTHER Linear Cutter Stapler can be applied in abdominal, Cutter Stapler gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
    Device Description
    The PANTHER Staplers were sterile(ETO), single-patient-use instruments which 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: PANTHER Circular Stapler: The PANTHER Circular Stapler places a circular, double staggered row of titanium staples in the tissue and resects the excess tissue, thus creating a circular anastomosis. PANTHER Circular Stapler includes 4 series: FCSM, FCSME, FCSMF, and FCSLWBE. PANTHER Hemorrhoidal Circular Stapler: The PANTHER Hemorrhoidal Circular Stapler places a circular, double staggered row of titanium staples in the tissue and resects the excess tissue, thus creating a circular anastomosis. The Hemorrhoidal Circular Stapler set includes a Hemorrhoidal Circular Stapler, Suture Threader, Circular Anal Dilator and Purse-string Suture Anoscope. PANTHER Hemorrhoidal Circular Stapler includes 4 series: FCSS, FCSSME, FCSSWAE and FCSSWBE. PANTHER Linear Stapler: The PANTHER Linear Stapler places a double or triple staggered row of titanium staples used for mechanical suturing and closure of tissue, prior to the removal of excess tissue. and is available in 30 mm, 45 mm, 60 mm, 75 mm and 90 mm staple 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. PANTHER Linear Stapler includes 2 series: FLSL, FLSLE PANTHER Linear Cutter Stapler: The PANTHER Linear Cutter Staplers place two double staggered rows of titanium staples in organs and tissues to anastomose the internal tissues and simultaneously cut and divide between the two rows during surgical procedures. The PANTHER Linear Cutter Staplers is available in six staple line lengths (55, 60, 75, 80, 100 or110mm). 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. PANTHER Linear Cutter Stapler includes 2 series: SSAA, SSAB.
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