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510(k) Data Aggregation

    K Number
    K170703
    Device Name
    Single Use Arthroscopic Electrode (with Pencil)
    Manufacturer
    Modern Medical Equipment Manufacturing Limited
    Date Cleared
    2018-05-31

    (449 days)

    Product Code
    HRX, GEI
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Modern Medical Equipment Manufacturing Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Single Use Arthroscopic Electrodes are indicated for single-use under sterile conditions with an electrosurgical pencil, a generator, neutral electrode and contact quality monitor (CQM) to deliver monopolar radiofrequency (RF) energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures.
    Device Description
    Single Use Arthroscopic Electrodes are monopolar active devices, which consists of a conductive electrode tip, an insulated shaft and a conductive post. The conductive electrode tip configuration offers 90° Angled Hook, 45° Angled Hook and Blade to meet the needs of Arthroscopy. The conductive electrode tip is the conductive portion of the electrode which delivers RF energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures. The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material (Polyolefin Shrinkage tube and / or PTFE Shrinkage tube) in order to prevent accidental conduction of the electrosurgical current from this point to the patient. An over-mold cap is attached at the end of electrode. The conductive post is used to plug the electrode into the distal end of an electrosurgical pencil from which it receives the electrical current. The post size of electrode is 2.36mm in diameter which fits insertion to the distal end of electrosurgical pencils in the legal market. The maximum rated accessory voltage is 2.9kVp. The maximum power setting of electrosurgical generator is 120 Watts.
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    K Number
    K163442
    Device Name
    Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)
    Manufacturer
    Modern Medical Equipment Manufacturing Limited
    Date Cleared
    2017-09-28

    (294 days)

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

    Modern Medical Equipment Manufacturing Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure
    Device Description
    The Single Use Micro Electrodes are the monopolar active device which consist of a conductive electrode tip, an insulated shaft and a conductive post. The conductive electrode tip configuration includes micro needles, scalpel blade, ball, broadbent, wire, triangle loop, diamond loop and round loop. The conductive electrode tip is the conductive portion of the electrode which delivers high frequency current onto a soft tissue for cutting and coagulation during an electro-surgery The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material included Polyolefin and /or PTFE Shrink Wrap, overmold, in order to prevent accidental conduction of the electrosurgical current from this point to the patient. The conductive post is used to pluq the electrode into the nozzle of an electrosurgical pencil from which it receives the electrical current. The diameter of the conductive post is available in 2.36mm and 1.6mm. This device is used in conjunction with electrosurgical pencil, a compatible monopolar electrosurgical generator and patient grounding pad during electrosurgical procedure.
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    K Number
    K152059
    Device Name
    Disposable General Electrode
    Manufacturer
    MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
    Date Cleared
    2016-04-21

    (272 days)

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

    MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure.
    Device Description
    Disposable General Electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is categorized by three families: Blade, Needle and Ball. Each electrode family offers three series S, M and L in length and different insulation designs. The conductive post of electrode is inserted into the nozzle of electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in electrosurgical procedure. This device is used in conjunction with a compatible monopolar electrosurgical generator and patient grounding pad and complies with IEC60601-1 and IEC60601-2-2.
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    K Number
    K134006
    Device Name
    DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE
    Manufacturer
    MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
    Date Cleared
    2014-11-21

    (329 days)

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

    MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The electrode is used to cut and coagulate the selected tissue for laparoscopic procedures.
    Device Description
    Disposable Laparoscopic Electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is either coated or non-coated and the conductive post is either 2.36mm or 4mm. The conductive post is inserted into the electrode entry of electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in laparoscopic procedure. During the operation, the electrode tip and the insulated shaft are to be inserted through a 5mm trocar. This device is used in conjunction with a compatible electrosurgical generator and patient grounding pad and complies with IEC60601-1 and IEC60601-2-2.
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