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510(k) Data Aggregation

    K Number
    K250212
    Device Name
    LapBox Power Tissue Containment System
    Manufacturer
    ARK Surgical
    Date Cleared
    2025-04-15

    (81 days)

    Product Code
    PMU, GCJ
    Regulation Number
    884.4050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARK Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LapBox Power Tissue Containment System is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The LapBox is compatible with electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation. When used in women with fibroids, the LapBox Power Tissue Containment System is for women who are pre-menopausal and under age 50.
    Device Description
    The LapBox Power Tissue Containment System is a single use sterile device. It is comprised of a double wall inflatable polyurethane chamber which is mounted on an insertion shaft and is provided with two port sizes. Once the shaft is inserted to the abdominal cavity, the chamber is deployed and the organ to be morcellated is placed within the chamber. The chamber is then inflated using an external handpump and the sleeve of the chamber is exteriorized. The selected port is then placed over the sleeve in the incision site and the organ can be morcellated using a power morcellator. Once morcellation is complete, the port is removed, and the chamber is deflated and removed from the patient.
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    K Number
    K221365
    Device Name
    LapBox Tissue Containment Removal System
    Manufacturer
    ARK Surgical, Ltd.
    Date Cleared
    2022-08-25

    (105 days)

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

    ARK Surgical, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LapBox Tissue Containment Removal System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.
    Device Description
    The LapBox Tissue Containment Removal System is a single use sterile device. It is comprised of a double wall inflatable polyurethane chamber which is mounted on an insertion shaft and is provided with two port sizes. Once the shaft is inserted to the abdominal cavity, the chamber is deployed and the organ to be morcellated is placed within the chamber. The chamber is then inflated using an external handpump and the sleeve of the chamber is exteriorized. The selected port is then placed over the sleeve in the incision site and the organ can be manually morcellated. Once morcellation is complete, the port is removed, and the chamber is deflated and removed from the patient.
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