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510(k) Data Aggregation

    K Number
    K242204
    Device Name
    Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC)
    Date Cleared
    2024-09-25

    (61 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dongguan Quanding Medical Supplies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable neutral electrodes are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient. Solid Electrosurgical pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical pads are for use with generators that have a CQMS (i.e. REM,ARM,NESSY etc.).
    Device Description
    Disposable neutral electrodes are part of a family of patient return electrodes. They are non-sterile, single-use devices used in electrosurgery to complete the electrical circuit with the generator. Providing a low-impedance path back to the generator through the return electrodes helps to prevent unintended HF burns. The solid electrosurgical pads are designed to be compatible with generators without Contact Quality Monitoring System (CQMS), and the split electrosurgical pads are designed to be compatible with the Contact Quality Monitoring System (CQMS) of compatible generators. The models share the same design elements (functional design, technology design, packaging, etc.) but have different sizes and shapes. The models are designed for adults, children, and neonates, separate catalog numbers are assigned for the intended patients, and pre-attached cord. Disposable neutral electrodes consist of foam backing, cable connection area, conductive aluminum foil, conductive adhesive gel layer and release liner. The pads are applied on a release liner. The surface of the conductive aluminum foil is fully covered with a soft, conformable conductive adhesive gel. The electrode backing is made of foam material. The electrodes are supplied with or without cable. For the non-corded pads, a reusable cable is not available as an accessory.
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