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510(k) Data Aggregation

    K Number
    K160366
    Device Name
    Electrosurgical disposable grounding pads
    Manufacturer
    TOP-RANK Health Care Co., Ltd
    Date Cleared
    2016-08-19

    (192 days)

    Product Code
    ODR
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    ODR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrosurgical disposable grounding pads are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.
    Device Description
    Electrosurgical disposable grounding pads construct of a layer of conductive aluminum foil with a foam as the supportive base of the pad. The aluminum foil is coated with adhesive hydro-gel layer. There is another film placed above the adhesive hydro-gel layer, which is used to protect the gel during the transportation and storage and will be removed prior to use. They are available in different combinations of configurations, types, intended populations and conductive area. They are not provided in sterile conditions and not required to be sterilized by the end user prior to operation. However, they are for single use only.
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    K Number
    K121268
    Device Name
    WANDY DISPERSVIE ELECTRODE
    Manufacturer
    BIO-MED USA INC.
    Date Cleared
    2012-12-20

    (238 days)

    Product Code
    ODR
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    ODR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wandy's Dispersive Electrode is intended use to the patient during Electrosurgical procedures to provide a path for RF current to leave the patient and return to the Generator
    Device Description
    Wandy Dispersive Electrode is designed to provide a safe return path Electrosurgical current between Generator, to active electrode and to patient without cord. And able to use to any patient if full skin contact available. non sterilized and to use only one time. The surface of the conductive area is covered with a Bio-compatible Hydro-gel and the surface of the non-conductive area made of PE Foam and Texture Fabric is covered with Medical grade adhesive for maximum skin adhesion. This device are non sterilized and one time use only, available 3 sizes with various shape for Adult / Pediatric
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    K Number
    K082204
    Device Name
    SERIES SY DISPOSABLE ELECTROSURGICAL PAD
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2008-08-13

    (8 days)

    Product Code
    ODR
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    ODR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ventlab Disposable Electrosurgical Pad is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
    Device Description
    Not Found
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