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510(k) Data Aggregation

    K Number
    K030838
    Device Name
    WARTNER PRO
    Manufacturer
    WARTNER MEDICAL PRODUCTS
    Date Cleared
    2003-06-27

    (102 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    WARTNER MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WARTNER PRO® is intended for the treatment of common warts and plantar warts in adults and children over the age of 4. Common warts are recognized by the rough 'cauliflower-like' appearance ci the surface. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern. The product is intended as an OTC device, which will be marketed to professionals, allied professionals, and semi-professionals.
    Device Description
    WARTNER PRO® is a cryosurgical system for the treatment of warts. It consists of - A canister filled with 125 ml of a liquid mixture of the compressed gases . dimethyl ether and propane. This gas mixture does not harm the ozone layer, and has a four-year shelf life. - 42 Foam applicators in three different sizes (6 mm, 7 mm, 8 mm) . - An applicator stick/key for holding a foam applicator which is required to . dispense the liquid to the applicator, and is held by the person during treatment - . Information booklet The pressurized canister is filled with dimethyl ether and propane, which acts as a cryogen. The key is fitted with a foam applicator, which is inserted into the safety valve opening in the canister. The valve releasing the cryogen can only be actuated when the key is in place and depressed. When the key is depressed it saturates the foam applicator with the cold cryogenic gases and lowers the temperature of the applicator to approximately -50℃. The foam applicator is then placed on the wart. The freezing kills the wart and the infected skin causing the wart to fall off within a few days.
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    K Number
    K011708
    Device Name
    MODIFICATION TO WARTNER WART REMOVAL SYSTEM
    Manufacturer
    WARTNER MEDICAL PRODUCTS
    Date Cleared
    2002-02-20

    (261 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    WARTNER MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wartner Wart Removal System is intended for the over-the-counter treatment of common warts.
    Device Description
    Wartner Wart Removal System is a cryosurgical system for the treatment of warts. It consists of - A canister filled with 35 ml of a liquid mixture of the compressed gases . dimethyl ether and propane. This gas mixture does not harm the ozone layer, and has a four-year shelf life. - . Ten foam applicators - . An applicator stick/key for holding a foam applicator, required to dispense the liquid to the applicator, and held by the person during treatment - An illustrated description of how to use the product .
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    K Number
    K002714
    Device Name
    WARTNER WART REMOVAL SYSTEM
    Manufacturer
    WARTNER MEDICAL PRODUCTS
    Date Cleared
    2000-11-28

    (89 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    WARTNER MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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