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510(k) Data Aggregation
K Number
K143669Device Name
MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
Manufacturer
MEDGYN PRODUCTS, INC.
Date Cleared
2015-11-23
(334 days)
Product Code
MQF
Regulation Number
884.6110Why did this record match?
Applicant Name (Manufacturer) :
MEDGYN PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MedGyn IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.
Device Description
MedGyn straight IUI, mini IUI, and curved, mini IUI catheters are used for intrauterine insemination for delivery of washed spermatozoa through the cervical os. The straight IUI is composed of a 21.4 cm length tube with subparts consisting of a polyethylene tube connecting with a polypropylene tube. The outer diameter of the polyethylene tube is 2.1 mm. That of the polypropylene tube is 2.75 cm. The tube is connected proximally to an ABS connector for attachment to a syringe. The mini IUI is exactly the same as the straight IUI except that the outer diameter of the inner polyethylene tube is 1.6 mm. The curved, mini IUI is exactly the same as the mini IUI except that it is slightly curved at its distal tip.
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K Number
K122973Device Name
AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
Manufacturer
MEDGYN PRODUCTS, INC.
Date Cleared
2013-06-12
(259 days)
Product Code
HEX
Regulation Number
884.1630Why did this record match?
Applicant Name (Manufacturer) :
MEDGYN PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MedGyn's Digital Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from the Digital Video Colposcope are to be viewed on a color monitor. The Digital Video Colposcope is intended for use in hospitals, clinics, and doctors' offices.
Device Description
The MedGyn Digital Video Colposcope, models AL-106, AL-106SA and AL-106B (collectively, the "MedGyn Colposcope"), has the same application as traditional colposcopes. However, while traditional optical colposcopes use binocular eyepieces for magnification, the MedGyn Colposcope uses electronic imaging technology to assist doctors in reviewing, checking, analyzing, and diagnosing abnormalities or lesions of the vulva, vagina, cervix and external genitalia. It is designed to be used in hospitals, doctors' offices and clinics by qualified or trained personnel.
The MedGyn Colposcope is an active, non-contact examination device. It uses a HAD CCD color digital video camera with a digital magnification of up to 40x (or only 32x for model AL-106B), a field of view of 52° at 1x and 2° at 32X, and a green filtered light source. The camera is attached to a floor stand; model AL-106SA has a swing-arm floor stand. A cable coming from the bottom of the floor stand connects to the signal conversion box. The customer then uses the composite video cable or the s-video cable to connect a commercially available monitor to the conversion signal box.
Tissue is magnified and viewed on the doctor's own computer monitor (not included with device). Both the doctor and the patient can observe the monitor's screen, thus helping the doctor explain the abnormalities and the suggested treatments to the patient, and allowing patient to see the abnormalities for herself and better understand her medical situation.
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