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Found 7 results
510(k) Data Aggregation
K Number
K010365Device Name
ORTHO CONTROL FEMALE URINARY CONTROL DEVICE
Manufacturer
PERSONAL PRODUCTS CO.
Date Cleared
2001-04-30
(82 days)
Product Code
MNG
Regulation Number
876.5160Why did this record match?
Product Code :
MNG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983164Device Name
RESTORE (AKA RE/STOR)
Manufacturer
NEBL, INC.
Date Cleared
1999-03-05
(176 days)
Product Code
MNG
Regulation Number
876.5160Why did this record match?
Product Code :
MNG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Restore device is indicated for the prevention or decrease of episodes of urine leakage in women with stress incontinence.
Device Description
Restore Female Continence device is a simple, noninvasive suction cup which fits over the urinary meatus. Air is squeezed out of the device's cap while it is positioned over the urinary meatus. When the cap is released, the device self-adheres to the anterior vaginal wall over the meatus via suction. If inadequate suction occurs. Aquaphor or a petroleum based ointment can be applied to the outside rim of the device to enhance suction. The suction or negative pressure created by the device causes coaptation and occlusion of the meatus and, therefore, increased urethral resistance. The amount of negative pressure generated by the device is optimized to counteract increases in intraabdominal and intravesical pressure during valsalva, thereby decreasing or preventing leakage.
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K Number
K974600Device Name
UROMED PATCH
Manufacturer
UROMED CORP.
Date Cleared
1998-03-31
(112 days)
Product Code
MNG
Regulation Number
876.5160Why did this record match?
Product Code :
MNG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UroMed Patch is indicated for the prevention or decrease of urine leakage in women with stress urinary incontinence.
The UroMed Patch is indicated for the prevention or decrease of episodes of urine leakage in women with stress urinary incontinence.
Device Description
The UroMed Patch is a single use, disposable foam pad that is coated on one side with an adhesive gel. The patch is worn over the urethra between times of unination. The product is intended to prevent unine form escaping the environs of the urethra, and is replaced each time the patient urinates.
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K Number
K974645Device Name
FEMASSIST FLEXIBLE
Manufacturer
INSIGHT MEDICAL CORP.
Date Cleared
1998-02-12
(62 days)
Product Code
MNG
Regulation Number
876.5160Why did this record match?
Product Code :
MNG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The INSIGHT Medical FemAssist™ Flexible is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI).
Device Description
The INSIGHT Medical FemAssist™ device consists of a small, flexible, cylindrical, non-sterile device with a short profile which is manufactured from soft silicone material. The FemAssist™ fits over the external female urethral opening, between the labia, posterior to the clitoris and anterior to the vagina. The FemAssist™ is placed directly over the urettral opening where it is held in place by its own mild vacuum action, supporting and reinforcing the natural action of the muscles that control wine output and preventing accidental urine loss. Aquaphor oinment is applied to the device flange area prior to placing it over the urethral opening to help achieve a good seal. The flange area of the FemAssist™ Flexible device is thimer than that of the standard FemAssist™ cleared in K963858 for increased patient comfort.
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K Number
K971359Device Name
RESTORE (A.K.A. CAPSURE)
Manufacturer
NEBL, INC.
Date Cleared
1997-11-14
(217 days)
Product Code
MNG
Regulation Number
876.5160Why did this record match?
Product Code :
MNG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Restore Continence Device is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence. Although it can help control urinary incontinence, it will not correct the underlying cause of the condition.
Device Description
The Restore Female Continence device is a simple, non invasive suction cup device which fits over the urinary meatus. Similar to a suction cup, air is squeezed out of the device's cap while it is positioned over the urinary meatus. When the cap is released, the device self-adheres to the anterior vaginal wall over the meatus via self-suction. If inadequate suction occurs, Aquaphor or an equivalent ointment can be applied to the outside rim of the device to enhance adhesion. The suction or negative pressure created by the device causes coaptation and occlusion of the meatus and therefore, increased urethral resistance. The amount of negative pressure generated by the device is optimized to counteract increases in intra-abdominal and intravesical pressure during valsalva thereby decreasing or preventing leakage.
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K Number
K963858Device Name
FEMASSIST URINARY DEVICE
Manufacturer
INSIGHT MEDICAL CORP.
Date Cleared
1997-10-21
(391 days)
Product Code
MNG
Regulation Number
876.5160Why did this record match?
Product Code :
MNG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FemAssist™ is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI).
Device Description
The FemAssist™ device is a small (3.5cm in diameter) cylindrical device with a short profile (2.0cm in height) designed and constructed (molded) to fit over the female urethra, between the labia, posterior to the clitoris and anterior to the vagina. The FemAssist™ supports and reinforces the natural action of the muscles that control urine output and prevents accidental urine loss. The female urethra is located between the vagina and the clitoris, in the center of the area about 3cm in diameter. The FemAssist™ product is place by it's own mild vacuum action.
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K Number
K954215Device Name
MINIGUARD
Manufacturer
ADVANCED SURGICAL INTERVENTION, INC.
Date Cleared
1996-05-08
(243 days)
Product Code
MNG
Regulation Number
876.5160Why did this record match?
Product Code :
MNG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Miniguard is an external female continence device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence occurs when intraabdominal pressure exceeds urethral resistance as a result of physical stress such as coughing, laughing, or lifting heavy objects. The Miniguard is designed for women who experience urine leakage under conditions of physical stress.
Device Description
The Miniguard female continence device consists of a small pad that is coated on one side with a biocompatible polymer adhesive. The Miniguard is an external management device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence. The Miniguard's function is to provide occlusion of the urinary opening by creating a seal over the urinary opening. The foam pad backing is intended to facilitate application and removal and for user comfort.
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