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510(k) Data Aggregation

    K Number
    K250351
    Device Name
    Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2025-10-10

    (245 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K092309,K182408,K171158
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Single Use Electrosurgical Knife KD-612 Series is intended to be used to cut tissue using high-frequency current within the digestive tract in combination with an endoscope and electrosurgical units.

    The Single Use Electrosurgical Knife KD-620UR is intended to be used to cut tissue using high-frequency current within the digestive tract in combination with an endoscope and electrosurgical units.

    The Single Use Electrosurgical Knife KD-650 Series is intended to be used to cut tissue using high-frequency current within the digestive tract in combination with an endoscope and electrosurgical units.

    Device Description

    The Single Use Electrosurgical Knife was designed to be used with compatible Olympus endoscopes, A-Cord (power cable), and electrosurgical units to cut tissue using high-frequency current within the digestive tract. The subject device is inserted endoscopically into the body cavity and tissue is cut by applying a high frequency current. The subject device is a sterile (EO) single use electrosurgical knife comprised of a handle and an insertion portion. The handle portion consists of the body and the slider. The insertion portion consists of the distal end with one lumen for the stainless-steel cutting knife and the sheath portion. The slider extends the cutting knife from the distal end of the sheath/tube when pushed and retracts the cutting knife into the sheath/tube when the slider is pulled.

    The Single Use Electrosurgical Knife is available in three different models: KD-612, KD-620UR, and KD-650. The primary difference between the models is the tip shape of the distal end.

    The subject device has the same technological characteristics and similar design as the applicable predicate device.

    AI/ML Overview

    N/A

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