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510(k) Data Aggregation
K Number
K101440Device Name
GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012
Manufacturer
GENERIC MEDICAL DEVICES, INC.
Date Cleared
2010-06-18
(25 days)
Product Code
OTN
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
GENERIC MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GMD Universal Urinary Incontinence Sling™-1012 is indicated for use in women as a suburethral sling for the treatment of Stress Urinary Incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency.
Device Description
The GMD Universal Urinary Incontinence Sling™-1012 is a sterile, single use device for the treatment of female Stress Urinary Incontinence. The Universal Urinary Incontinence Sling™ 1012 is comprised of a polypropylene knitted mesh protected by a disposable polypropylene sheath with a surgical suture loop at each end for attachment of the sling to GMD's reusable T-slot trocars (sold separately). The surgical suture loop is used for inside-out / bottom-up and outside-in / top-down approaches. The method of placement and surgical approach chosen by the physician should be appropriate for the patient's diagnosis and anatomy.
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