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510(k) Data Aggregation

    K Number
    K063753
    Device Name
    GFX NERVE ABLATION SYSTEM
    Manufacturer
    ACI, INC.
    Date Cleared
    2007-06-20

    (183 days)

    Product Code
    GXD, GXI
    Regulation Number
    882.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lesion Probe and Generator system is intended to create radiofrequency (RF) heat lesions in nerve tissue. It is intended for use only by trained clinicians in a hospital or clinical setting.
    Device Description
    The GFX Nerve Ablation System provides a minimally invasive technique for creating a neural lesion inhibiting the function of the target nerve. The Generator and probe are used as a system to both stimulate the nerve for the purpose of locating the probe correctly and to create a neural lesion to inhibit nerve function through the application of RF energy. The GFX Nerve Ablation probes are single use devices supplied sterile to the customer.
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    K Number
    K061501
    Device Name
    FLEXO DENTAL RESIN MATERIAL
    Manufacturer
    ACI, INC.
    Date Cleared
    2006-07-26

    (56 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Flexo Dental Resin Material is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
    Device Description
    The Flexo Dental Resin Material is an injection moldable, flexible thermoplastics resin designed for fabricating removable dental appliances.
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