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510(k) Data Aggregation

    K Number
    K981220
    Device Name
    SYSTEM 7500 ABC ELECTROSURGICAL UNIT
    Manufacturer
    ASPEN LABORATORIES, INC.
    Date Cleared
    1998-04-21

    (18 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYSTEM 7500 ABC ELECTROSURGICAL UNIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Like the predicate devices, the proposed unit together with the same already marketed related predicate accessories is used for the controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit.

    Device Description

    System 7500 Electrosurgical Unit

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the "System 7500 Electrosurgical Unit". It states that the device is substantially equivalent to legally marketed predicate devices for the controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit.

    However, the provided text does not contain any information regarding acceptance criteria, device performance metrics, study details, sample sizes, ground truth establishment, or expert qualifications. The letter is purely regulatory in nature, indicating approval for marketing based on substantial equivalence.

    Therefore, I cannot fulfill your request for the detailed table and study information.

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