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510(k) Data Aggregation
K Number
K233548Device Name
Uresta®
Manufacturer
Resilia Inc.
Date Cleared
2024-04-03
(152 days)
Product Code
HHW
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
Resilia Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Uresta bladder support is indicated for use in adult women over 18 years of age who experience stress urinary incontinence (involuntary urine loss, such as a pee leak that occurs when you cough, laugh, sneeze or with some physical tasks).
Device Description
Uresta® is a bell-shaped vaginal bladder support that is intended to support the urethra to help reduce leaks caused by stress urinary incontinence. It has a tapered tip for insertion into the vaginal introitus and a handle end to enable placement and removal. It may also be used with a water-based lubricant for easier insertion. Uresta® is available in five (5) sizes, ranging from 34 mm (size 2) to 52 mm (size 6). It can be inserted in the morning and removed at bedtime every day or used just for specific activities such as exercise and removed after the activity. Uresta® is molded from non-latex thermoplastic rubber and is provided non-sterile for single patient use.
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