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510(k) Data Aggregation

    K Number
    K250275
    Device Name
    PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch
    Manufacturer
    Baylis Medical Technologies Inc.
    Date Cleared
    2025-10-28

    (270 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K122278
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PrecisePath Radiofrequency Puncture Generator and Footswitch (optional accessory) is indicated for use in general surgical procedures to cut and coagulate soft tissues.

    Device Description

    The PrecisePath Radiofrequency (RF) Puncture Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue. It is designed to be used by trained medical professionals, to provide radiofrequency (RF) current for creating controlled punctures with compatible Baylis RF devices in a monopolar mode. This continuous or pulsed RF current is output at a fixed frequency within 450 kHz to 480 kHz.

    The PrecisePath Footswitch (optional accessory) may be used as an alternative to the on/off button on the generator user interface by which the user can start and stop the delivery of RF energy.

    The PrecisePath RF Puncture Generator is compatible with separately cleared Baylis radiofrequency devices and connector cables, off-the-shelf return (dispersive) electrodes that meet or exceed IEC 60601-2-2:2017, and the PrecisePath footswitch (optional accessory).

    AI/ML Overview

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