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510(k) Data Aggregation

    K Number
    K092821
    Device Name
    TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021
    Date Cleared
    2010-02-01

    (140 days)

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

    AGENCY FOR MEDICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The "TissueBags" are intended for safe collection and removal of specimen, such as appendix, gallbladder, myoma, cysts, ovaries, fibroid tumours and other tissues, and calculi during surgical procedures.
    Device Description
    The TissueBags are intended as receptacles for safe collection and removal of specimen during surgical procedures. Removal is accomplished by positioning the bag that serves as a receptacle for the specimen, close to the specimen that is intended to be removed. The bag opens, and the feeding-mouth is kept open automatically. Closure of the filled bag is done either by pulling back the complete device, or by pulling back an integrated purse string only. The TissueBags comprise various types of retrieval bags, which share similarities of the basic functional principle, materials, Sterile-Barrier-Packaging, delivery status and sterilisation method. The TissueBags differ in the size of their bag (loading capacity), the availability of an integrated handle, respectively the need for being connected to an A.M.I.-dock Applicator pre-operatively and the possibility to disconnect the filled bag from the instrument. Each TissueBag consists of a bag, a suspension mechanism, a protection sleeve and a handle, that is either an integrated part of the device or attached in terms of an A.M.I.dock Applicator. One type of the TissueBags is additionally equipped with a purse string. All TissueBags are designed to be applicable with 10 mm ports for minimally invasive surgery. They are disposable, delivered sterile as single use devices. Their Sterile-Barrier-Packaging consists of two independently sealed pouches made from Tyvek and PET-foil. Sterilisation by means of Radiation guarantees a Sterility Assurance Level of 10° Biocompatibility evaluation has shown the TissueBags to meet the requirements of ISO 10993-1.
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