Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K210315
    Device Name
    Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps
    Manufacturer
    Modern Medical Equipment Manufacturing, LTD.
    Date Cleared
    2022-03-17

    (407 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Modern Medical Equipment Manufacturing, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Single Use Hand Switch Monopolar Forceps with Smoke Evacuation (CD954) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery. 2. Single Use Hand Switch Bipolar Forceps with Smoke Evacuation (CD955) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery. 3. Single Use Hand Switch Monopolar Forceps (CD956) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure. 4. Single Use Hand Switch Bipolar Forceps (CD957) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure.
    Device Description
    Modern Medical Electrosurgical Monopolar Forceps and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (monopolar or bipolar) to the specified output terminal of an electrosurgical generator. The forceps are intended for use with rated accessory voltage of 2.0kVp. The forceps are offered sterile (EtQ) and either as with or without smoke evacuation system which include four models, such as CD954, CD955, CD956 and CD957.
    Ask a Question
    K Number
    K211170
    Device Name
    Single Use Irrigation bipolar cable
    Manufacturer
    Modern Medical Equipment Manufacturing, LTD.
    Date Cleared
    2021-10-19

    (183 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Modern Medical Equipment Manufacturing, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to provide irrigation and energy simultaneously to standard bipolar forceps specifically designed for irrigation. The device is used with Malis bipolar coagulators or the compatible generators and the Malis CMC-II Irrigation Module or The Malis irrigation module 1000.
    Device Description
    The device is single use and is used to connect an irrigation bipolar forceps to electrosurgical generator and irrigation module for coagulation and delivering saline to the tip of forceps simultaneously. The socket connector of the cable is to fit Codman irrigating bipolar forceps. The fixed 2-pin plug is connected to any compatible generators or the flying lead connectors are connected to Malis bipolar coagulators or any compatible generators. The tubing set of the cable can be used with the Malis CMC-II irrigation module or the Malis irrigation module 1000.
    Ask a Question
    K Number
    K200372
    Device Name
    Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil
    Manufacturer
    Modern Medical Equipment Manufacturing, Ltd.
    Date Cleared
    2020-11-30

    (290 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Modern Medical Equipment Manufacturing, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is used to conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
    Device Description
    There are two main series of smoke evacuation pencil. (1) Smoke Evacuation Fingerswitch (PS947): The device includes the active handle which connects with the active electrode. The diameter of the mating part is 2.36mm+/-0.02mm. The buttons on the active handle control cutting and coagulation, the yellow side activates the cutting function and the blue side activates the coagulation function. The active handle's end is connected to an insulation cord with an active connector. The EVA tubing at the rear of the active handle then leads to a filter and pump system that facilitates the removal of harmful "surgical smoke" from the site of operation. The switching controls are mounted onto an active handle that moves freely up and down the shaft of the device when the device is in vertical position (or moves freely forward and backward when the device is in horizontal position), when the switching control moves freely on the shaft, distance between the front end of the handle and the controls is reduced or increased that works like extending and retracting the suction tip on general smoke evacuation, allowing the surgeon a greater degree of control and removing the need for additional accessories to extend the length of the device when working in cavities and other areas with restrictive access. Furthermore, the electrode can be exchanged with 63.5mm, 69mm and 120mm long electrodes in diameter 2.36±0.2mm with corresponding nosecone for further extending the length of suction tip for smoke evacuation. (2) Smoke evacuation system with electrosurgical pencil (CE809): The device includes electrosurgical pencil with electrode and smoke evacuation handle connected with EVA tubing with ID22mm tubing connector. Electrosurgical pencil (PD646 or PD631) with 69mm long electrodes in diameter 2.36±0.2mm, can be put into the handle that functions as smoke evacuation pencil.
    Ask a Question
    K Number
    K192542
    Device Name
    Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde
    Manufacturer
    Modern Medical Equipment Manufacturing, LTD.
    Date Cleared
    2020-06-16

    (274 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Modern Medical Equipment Manufacturing, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.
    Device Description
    The Electrosurgical Pencil with coated and non-coated electrode is the monopolar active device which consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrosurgical pencil consists of a plastic handle, electrical cable and a plug. The switching modes are for "CUT" and "COAG" function. A socket in front of the pencil casing is used to allow the insertion of an electrode. The electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip may be blade, ball and needle. The electrode tip is either coated or non-coated. The diameter of the conductive post is 2,36mm. The pencil with electrode is to be connected to a general high frequency electrosurgical generator by means of the electrical cable and is used in conjunction with a patient grounding pad during an electrosurgical procedure. The switching method of electrosuraical pencil may be push button, rocker switch or foot switch, cable length of the electrosurgical pencil will be around 3m to 5m with 3-pins plug or 1-pin plug, the lengths of the blade, needle and ball electrode may be around 69mm to152mm, with coated or non-coated.
    Ask a Question

    Page 1 of 1