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Found 14 results
510(k) Data Aggregation
K Number
K093479Device Name
DISPOSABLE SUCTION AND IRRIGATION SYSTEM
Manufacturer
MODERN MEDICAL EQUIPMENT MFG., LTD.
Date Cleared
2010-05-19
(191 days)
Product Code
FHF
Regulation Number
876.4370Why 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
K091511Device Name
MODERN MEDICAL RESECTOSCOPE ELECTRODES
Manufacturer
MODERN MEDICAL EQUIPMENT MFG., LTD.
Date Cleared
2010-01-15
(238 days)
Product Code
FAS
Regulation Number
876.4300Why 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
K070812Device Name
DISPOSABLE LAPAROSCOPIC INSTRUMENT
Manufacturer
MODERN MEDICAL EQUIPMENT MFG., LTD.
Date Cleared
2007-09-14
(172 days)
Product Code
GEI
Regulation Number
878.4400Why 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
K070877Device Name
ENDOCERVICAL ELECTRODE # 2
Manufacturer
MODERN MEDICAL EQUIPMENT MFG., LTD.
Date Cleared
2007-07-27
(120 days)
Product Code
HGI
Regulation Number
884.4120Why 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
K050842Device 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/AWhy 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
K043036Device Name
NON-STICK ELECTRODE
Manufacturer
MODERN MEDICAL EQUIPMENT MFG., LTD.
Date Cleared
2005-05-06
(183 days)
Product Code
GEI
Regulation Number
878.4400Why 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
K033095Device Name
SMOKE EVACUATION ATTACHEMENT
Manufacturer
MODERN MEDICAL EQUIPMENT MFG., LTD.
Date Cleared
2004-11-17
(415 days)
Product Code
GEI
Regulation Number
878.4400Why 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
K040238Device Name
SOFTSEAL HSG CATHETER
Manufacturer
MODERN MEDICAL EQUIPMENT MFG., LTD.
Date Cleared
2004-06-22
(148 days)
Product Code
LKF
Regulation Number
884.4530Why 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
K030831Device Name
LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS
Manufacturer
MODERN MEDICAL EQUIPMENT MFG., LTD.
Date Cleared
2004-06-15
(459 days)
Product Code
GEI
Regulation Number
878.4400Why 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
K032327Device Name
MODERN MEDICAL BIPOLAR FORCEPS
Manufacturer
MODERN MEDICAL EQUIPMENT MFG., LTD.
Date Cleared
2004-06-15
(323 days)
Product Code
GEI
Regulation Number
878.4400Why 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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