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510(k) Data Aggregation

    K Number
    K253198

    Validate with FDA (Live)

    Device Name
    NanoKnife Generator (H78720300351US0)
    Manufacturer
    Angiodynamics
    Date Cleared
    2026-03-24

    (179 days)

    Product Code
    OAB
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K242687
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue, including prostate tissue.

    Device Description

    The NanoKnife Generator is part of the NanoKnife System, and is a software-controlled low-energy direct-current (LEDC) generator which surgically ablates soft tissue, including prostate tissue. Included for use within the NanoKnife System are the NanoKnife Single Electrode Probes and optional Probe Spacer. With the NanoKnife System, a voltage applied between pairs of probes in a series of pulses. The waveform of the voltage is adjustable as determined by clinician-chosen parameters. These parameters include pulse length, number of pulses to be delivered between electrode pairs, the distance between probes, and the timing mode (90PPM or ECG synchronization). Up to six probes may be placed in an array within the tissue. The probes of the array are matched as pairs by the system. When probes are activated via a foot-pedal, the scheduled voltage is delivered to tissue subsequent pairs of probes. Soft tissue (including prostate tissue) between the probes is ablated.

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