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510(k) Data Aggregation

    K Number
    K252957

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-01-23

    (129 days)

    Product Code
    Regulation Number
    876.1500
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K140101

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

    The CO2 Pneumo-Dissector is used to dissect planes of soft tissue using pressure regulated, trigger-controlled pulses of medical grade CO2 gas. The device may be used in endoscopic, laparoscopic, and open procedures in which gentle blunt dissection of soft tissue planes is desired. Use the product only in accordance with the instructions provided.

    Device Description

    The Pneumo Dissector Hook is a standard monopolar hook (based on design cleared under K140101) that can deliver CO2 flow on demand during general endoscopy and laparoscopic surgery. It is composed of two parts, a handle and an insert, which are linked using a nut-screw system. Also, the distal part of the instrument has the hook shape which is the monopolar electrode and the gas nozzle. It is a surgically invasive device intended for delivering pressurized CO2 gas to achieve separation of tissue layers prior to their dissection. The hook insert and tube are offered in lengths of 330mm and 200mm and diameters of 3.5mm and 5.0mm.
    The handle has a connector for the CO2 as well as the banana plug or connector for electrosurgery. There is a push button to activate the CO2.
    The nut-screw system is used to link the handle to the insert.
    The insert consists of an insulated tube with a hook on the distal end.
    The hook insert and tube are available in lengths of 330mm and 200mm and diameters of 3.5mm and 5.0mm.

    AI/ML Overview

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