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510(k) Data Aggregation

    K Number
    K123728
    Device Name
    RETRIEVAL BAG
    Manufacturer
    FLEXBAR MACHINE CORP.
    Date Cleared
    2013-12-11

    (372 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLEXBAR MACHINE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mediflex device is a laparoscopic tissue retrieval bag model 24003-MF. The sterile bag is a single use disposable device used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures.
    Device Description
    The Mediflex device model 24003-MF is for endoscopic retrieval of tissue. It consists of a sterile pouch bag wrapped in coated paper inside a Tyvek peel pouch that is a single use, disposable and durable device. The pouch bag is made of polyurethane coated polyamide. It is suitable for collection and extraction of tissue through 10, 11 or 12mm cannula during laparoscopic surgical procedures. The sterile pouch bag construction is suitable for function and made for opening and closure during the surgical retrieval process. The outer Tyvek peel pouch is marked with the device identification.
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    K Number
    K103840
    Device Name
    CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE
    Manufacturer
    FLEXBAR MACHINE CORP.
    Date Cleared
    2011-02-28

    (80 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLEXBAR MACHINE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable accessory Laparoscopic Scissor Tips and Handle are used for electrical and nonelectrosurgical procedures intended for providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures.
    Device Description
    The Laparoscopic Scissor Tips are accessory disposable components that attach to the reusable Laparoscopic Surgical Handle. Laparoscopic Scissor Tips are assembled from medical grade stainless steel and sterilized for single use with the reusable surgical handle that must be cleaned and sterile before use. The Edge System is used with a standard electrosurgical generator and is a monopolar system. The handle is a standard insulated monopolar type with an insulated shaft.
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