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510(k) Data Aggregation

    K Number
    K093479
    Device Name
    DISPOSABLE SUCTION AND IRRIGATION SYSTEM
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2010-05-19

    (191 days)

    Product Code
    FHF
    Regulation Number
    876.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MODERN MEDICAL EQUIPMENT MFG., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Suction And Irrigation System is used to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to remove fluid waste, tissue debris and smoke from the surgical site.
    Device Description
    The Disposable Suction And Irrigation System is composed of a stainless steel Suction / Irrigation Probe which is connected to a handle having two trumpet type valves. Using the fingers, the action of depressing one valve will control the irrigation fluid from the Poly Venyl Chloride (PVC) tubing through the irrigation probe and be delivered onto the site of surgery. By depressing the other valve would enable the action of suction to remove blood and tissue debris from the site of surgery through the suction probe and these will be transported through the PVC tubing and be deposited into a waste container. The handle is joined to two PVC tubes. One divides itself into two branches to conduct irrigation fluids from a saline bag. The clamp is used to hold the two tubes in a vertical position. This irrigation fluid passes down the tubes, then through the Suction / Irrigation Probe and is deposited onto the surgical site. The other tube will conduct waste tissue debris or blood or smoke. A vacuum pump will be connected to the Suction end to draw the tissue debris or blood or smoke from the site of surgery, through the stainless steel Suction / Irrigation Probe and these are transported through this PVC tubing until they are deposited into a waste container. This device is for single use only.
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    K Number
    K091511
    Device Name
    MODERN MEDICAL RESECTOSCOPE ELECTRODES
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2010-01-15

    (238 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MODERN MEDICAL EQUIPMENT MFG., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is a monopolar electrode intended for ablation and coagulation of soft tissues by means of electrical energy delivered by an electrical generator. It is used with compatible resectoscopes .
    Device Description
    Not Found
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    K Number
    K070812
    Device Name
    DISPOSABLE LAPAROSCOPIC INSTRUMENT
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2007-09-14

    (172 days)

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

    MODERN MEDICAL EQUIPMENT MFG., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The instrument is used to cut and coagulate the selected tissue for Laparoscopic procedure.
    Device Description
    Not Found
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    K Number
    K070877
    Device Name
    ENDOCERVICAL ELECTRODE # 2
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2007-07-27

    (120 days)

    Product Code
    HGI
    Regulation Number
    884.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    MODERN MEDICAL EQUIPMENT MFG., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endocervical Hysterectomy Electrode is indicated for treatment of following Condition 1. Excision of inner cervix during supracervical hysterectomy.
    Device Description
    Not Found
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    K Number
    K050842
    Device Name
    AGCEL WOUND DRESSING,AGCEL BURN DRESSING
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2006-08-02

    (488 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MODERN MEDICAL EQUIPMENT MFG., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Modern Medical Antimicrobial Wound Dressing & Modern Medical Antimicrobial Burn Dressing are used for first aid management of minor abrasions, cuts, scrapes, scalds and burns.
    Device Description
    Modern Medical Antimicrobial Wound Dressing is made up of darker viscose polyester layer and a lighter layer of non-woven cloth. The darker layer contains nano silver ions (0.5 mg per g) about 1-100 nm in diameter, these provide a barrier protection against microbes. The lighter layer is designed to protect the wound surface. Modern Medical Antimicrobial Burn Dressing is totally made of unwoven cloth. The thicker and stronger texture also contains silver ions (2.6 mg per g) in order to form an effective barrier against microbes. It is intended to be applied directly onto the wound and cover with conventional methods.
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    K Number
    K043036
    Device Name
    NON-STICK ELECTRODE
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2005-05-06

    (183 days)

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

    MODERN MEDICAL EQUIPMENT MFG., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is an electrosurgical cutting and coagulating device intended to remove tissues and control bleeding by means of high frequency electrical current.
    Device Description
    Not Found
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    K Number
    K033095
    Device Name
    SMOKE EVACUATION ATTACHEMENT
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2004-11-17

    (415 days)

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

    MODERN MEDICAL EQUIPMENT MFG., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications For Use: The Smoke Evacuation Attachment is intended to remove smoke and aerosols from the surgical site.
    Device Description
    Not Found
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    K Number
    K040238
    Device Name
    SOFTSEAL HSG CATHETER
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2004-06-22

    (148 days)

    Product Code
    LKF
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    MODERN MEDICAL EQUIPMENT MFG., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Softseal Catheter (a uterine manipulator/injector) is used to access the uterine cavity for the injection and retention of contrast fluid (or gas) into the uterus to enable the visualization of the uterine cavity and fallopian tubes. This device is not for intrafallopian procedure. The following clinical indications are some of the applications: 1. Infertility 2. Menorrhagia 3. Dysmenorrhea Due to Uterine Synechia 4. Suspected Endometrial Polyp 5. Submucous Fibroid 6. Uterine Synechia (Asherman Syndrome) 7. Congenital Uterine Abnormality
    Device Description
    Softseal HSG Catheter (a uterine manipulator/injector)
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    K Number
    K030831
    Device Name
    LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2004-06-15

    (459 days)

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

    MODERN MEDICAL EQUIPMENT MFG., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The instrument is used to cut and coagulate the selected tissue for Laparoscopic procedure.
    Device Description
    Not Found
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    K Number
    K032327
    Device Name
    MODERN MEDICAL BIPOLAR FORCEPS
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2004-06-15

    (323 days)

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

    MODERN MEDICAL EQUIPMENT MFG., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to facilitate tissue grasping and control the bleeding of small vessel by bipolar coagulation
    Device Description
    Reusable bipolar forceps
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