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510(k) Data Aggregation

    K Number
    K171041
    Device Name
    SilverSeal
    Date Cleared
    2017-08-22

    (137 days)

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

    Alliqua BioMedical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For Over-the-Counter Use: SilverSeal Hydrogel Wound Dressing made with X-Static is indicated for the topical management of minor superficial wounds, minor lacerations, minor abrasions and minor first degree burns.
    Device Description
    Hydrogel Wound Dressings with X-Static are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. Hydrogel Wound Dressings with X-Static are made of flexible sterile nonadherent hydrogel consisting of water and polymer with nylon fibers coated with metallic silver suspended in the hydrogel.
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    K Number
    K162721
    Device Name
    Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator
    Date Cleared
    2016-12-22

    (84 days)

    Product Code
    Regulation Number
    878.4410
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLIQUA BIOMEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MIST Systems produce a low energy ultrasound generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates, and bacteria.
    Device Description
    MIST Systems (e.g., UltraMIST System) are low frequency ultrasound devices, which utilize a fluid (e.g., saline) mist to deliver the ultrasound to the treatment site. The atomized fluid allows the treatment to be performed without direct contact to the patient. MIST Systems are made up of a main generator component, treatment wand, and disposable applicator. MIST Systems deliver low-frequency ultrasound to the treatment site using an atomized fluid mist. The mist is generated from a small, portable system consisting of a generator, a treatment wand (encasing an ultrasound transducer), and a disposable applicator that has been designed to connect to a user-provided fluid source (e.g., IV saline bag). The system provides a flow of fluid (irrigant) to the tissue surface by the use of low frequency, low intensity ultrasound. Only the mist touches the tissue, not the ultrasound radiation surface (horn tip), thus the term "non-contact" ultrasound. The flow of fluid as an irrigant is controlled by a peristaltic pump on the generator unit. The fluid is dispensed onto the ultrasound radiation surface where the mist is generated. The mist is projected by fundamental atomization or nebulization and acoustic streaming or acoustic radiation force respectively.
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