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510(k) Data Aggregation

    K Number
    K032671
    Device Name
    GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07
    Manufacturer
    GEBAUER CO.
    Date Cleared
    2004-03-17

    (201 days)

    Product Code
    MLY,DEV
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K031036
    Predicate For
    K162218,K172028,K172598,K190161
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) Topical Anesthetic: a vapocoolant (skin refrigerant) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds. Gebauer's Skin Refrigerant controls pain associated with minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses, and sutures), injections (venipuncture, IV starts, cosmetic procedures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). The Medium Spray is also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.

    Device Description

    Gebauer's Skin Refrigerant (Mist and Medium Spray) Topical Anesthetic is a prescription device designed to deliver 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,2-Tetrafluoroethane) in a mist and medium spray. This mixture self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device delivery system is specifically designed to deliver a medium and mist spray of the Gebauer's Skin Refrigerant (Mist Spray and Stream Spray) mixture. The medium and mist spray is an appropriate mode of application when users follow directions for use, cooling the skin through rapid evaporation of the non-medicated volatile propellants.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called Gebauer's Skin Refrigerant. It focuses on demonstrating substantial equivalence to a predicate device and expanding indications for use. It does not contain any acceptance criteria or details of a study that proves the device meets specific performance metrics.

    Therefore, I cannot populate the table or answer the questions as requested, because the necessary information is not present in the provided document. The submission states that the new device is "identical in formulation, delivery system and packaging to the predicate device" and that the "expansion of the indications for use is based on FDA's Blue Book #G95-1 and ISO-10993," which are regulatory guidelines and standards, not specific performance studies.

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