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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
ADVANCED SURGICAL INTERVENTION, INC.
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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