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510(k) Data Aggregation

    K Number
    K120902
    Device Name
    GID 700
    Manufacturer
    THE GID GROUP, INC.
    Date Cleared
    2012-08-15

    (142 days)

    Product Code
    MUU
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE GID GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GID 700 is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation. The GID 700 is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.
    Device Description
    The GID Group's GID 700 device is a sterile, single use 700 ml canister and accessories used to receive and filter tissue from lipoplasty procedures. When the tissue is deposited into the canister, it is filtered through a mesh filter to capture the tissue. The vacuum source is user or institution supplied. Various ports on the canister provide access to the vacuum source, receives the harvested tissue, vent the canister during the wash process, and transfer the filtered tissue.
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