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510(k) Data Aggregation

    K Number
    K240635
    Device Name
    ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm
    Manufacturer
    Date Cleared
    2024-04-01

    (26 days)

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

    Ximedica

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ENDOCOLLECT Specimen Retrieval Bag is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
    Device Description
    The ENDOCOLLECT Specimen Retrieval Bag ("ENDOCOLLECT") is a disposable device used as a receptacle for the collection and extraction of tissue specimens during laparoscopic surgery and is intended to be used with an endoscopic trocar. ENDOCOLLECT is comprised of a flexible plastic bag with a large, easily accessible opening, a spring finger, deployment shaft, shaft handle, and an insertion tube. In the fully deployed condition, the specimen bag opening is maintained during the retrieval of a specimen. When the specimen is placed in the bag, the bag is closed with the cinch cord and the device may be removed from the body.
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    K Number
    K232519
    Device Name
    ENDOCOLLECT Specimen Retrieval Bag
    Manufacturer
    Date Cleared
    2024-01-05

    (140 days)

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

    Ximedica

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ENDOCOLLECT Specimen Retrieval Bag is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
    Device Description
    The ENDOCOLLECT Specimen Retrieval Bag ("ENDOCOLLECT") is a disposable device used as a receptacle for the collection and extraction of tissue specimens during laparoscopic surgery and is intended to be used with an endoscopic trocar. ENDOCOLLECT is comprised of a flexible plastic bag with a large, easily accessible opening, a spring finger, deployment shaft, shaft handle, and an insertion tube. In the fully deployed condition, the specimen bag opening is maintained during the retrieval of a specimen. When the specimen is placed in the bag, the bag is closed with the cinch cord and the device may be removed from the body.
    Ask a Question

    Ask a specific question about this device

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