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Found 5 results
510(k) Data Aggregation
K Number
K974040Device Name
C3 EXTERNAL MALE BLADDER CONTROL DEVICE
Manufacturer
TIMM RESEARCH CO.
Date Cleared
1998-07-14
(263 days)
Product Code
FHA
Regulation Number
876.5160Why did this record match?
Product Code :
FHA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The C3® External Male Bladder Control Device is intended to be used for the management of urinary incontinence in males.
Device Description
The C3® External Male Bladder Control Device is a disposable, externally applied occlusive device intended to manage urinary incontinence in males. The male urethra is occluded by applying an external force on the base of the dorsal side of the penile shaft by means of a clamp.
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K Number
K971992Device Name
UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)
Manufacturer
UROMED CORP.
Date Cleared
1997-08-01
(64 days)
Product Code
FHA
Regulation Number
876.5160Why did this record match?
Product Code :
FHA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UroMed ABC device is intended to prevent or reduce episodes of male urinary incontinence.
The UroMed ABC device is indicated to prevent or reduce episodes of male urinary incontinence.
Device Description
The UroMed ABC device is a urological clamp designed to significantly reduce the leakage of urine by occluding the urethra. The ABC device is clamped on the glans of the penis to provide less compression, yet the same continence as those urological clamps that are placed on the shaft of the penis.
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K Number
K970308Device Name
MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE
Manufacturer
MENTOR UROLOGY, INC.
Date Cleared
1997-04-02
(65 days)
Product Code
FHA
Regulation Number
876.5160Why did this record match?
Product Code :
FHA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is indicated for any male, who has urinary incontinence, either on a temporary or long term basis. It is also indicated for those patients who have an adverse reaction to natural latex rubber.
Device Description
The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is a two piece compression device for males with urinary incontinence. The device consists of a silicone gel filled penile compression wrap for occlusion of the urethra and a silicone ring. It is intended for users who would prefer a reusable soft sided device instead of a rigid clamping device. The device is intended for users with moderate to heavy urinary incontinence to provide a temporary means of urinary continence.
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K Number
K964580Device Name
CAP-AID (IMPROVED)
Manufacturer
NEBEL, INC.
Date Cleared
1997-01-10
(56 days)
Product Code
FHA
Regulation Number
876.5160Why did this record match?
Product Code :
FHA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NEBL CAP-AID (Improved) is designed to effectively occlude the male meatus thereby preventing urinary leakage.
The product prevents urinary leakage in men with urinary incontinence.
Device Description
The CAP-AID (Improved) is exactly similar in indications, design and features to the original CAP-AID device. Only the materials are different. The material changes requested in the "Improved" version allow additional comfort and ease of use for the patient.
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K Number
K955810Device Name
U-TEX
Manufacturer
LABORIE MEDICAL TECHNOLOGIES, LTD.
Date Cleared
1996-01-24
(29 days)
Product Code
FHA
Regulation Number
876.5160Why did this record match?
Product Code :
FHA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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