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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
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SERIES SY DISPOSABLE ELECTROSURGICAL PAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Ventlab Corporation regarding their Disposable Electrosurgical Pad. This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as would be found in a study report summarized for such a request.

    Therefore, I cannot fulfill your request for the specific details outlined in the prompt from this document. The document primarily focuses on:

    • The FDA's determination of substantial equivalence for the device.
    • Regulatory requirements and general controls provisions.
    • Instructions for marketing the device.
    • Contact information for various FDA offices.
    • The intended use of the device.
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