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510(k) Data Aggregation

    K Number
    K970576
    Device Name
    SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615)
    Manufacturer
    SOMNUS MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-04-09

    (55 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Somnus™ Model 615 Electrosurgical Generator and Accessories are intended for use with the Somnus Soft Tissue Coagulating Electrodes for the coagulation of soft tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

    The Somnus Model 615 Electrosurgical Generator and Soft Tissue Coagulating Electrodes are intended for use in the coagulation of soft tissue.

    Device Description

    The Somnus™ Model 615 Electrosurgical Generator is an electrosurgical generator has controls for maximum temperature, power delivered, energy delivered and time of energy delivery. The unit has readouts for total energy delivered, impedance, maximum power, temperature for up to 18 thermocouples. Connectors on the front panel include connectors for electrodes and a footpedal.

    Accessories included with the generator include a line power cable and a single pedal footpedal.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets such criteria. The document describes an electrosurgical generator, its intended use, and a comparison to predicate devices, but it does not detail any specific performance metrics, clinical studies, or acceptance criteria.

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