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U.S. Department of Health and Human Services

Product Classification

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Device mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Regulation Description Surgical mesh.
Definition Transvaginal surgical repair of female stress urinary incontinence (sui) due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility.
Physical State Non-synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, etc.); design can be pre-configured or can be a sheet to allow surgeon to cut the mesh to desired size and shape.
Technical Method Placed under the urethra transvaginally using a transobturator (one vaginal incision and two groin/upper thigh incisions) or retropubic (one vaginal incision and two abdominal incisions) approach; during instances of increased abdominal pressure (e.g., coughing, laughing, sneezing, etc.) the device applies pressure to the urethra to prevent urine leakage.
Target Area urethra, vagina
Regulation Medical Specialty General & Plastic Surgery
Review Panel Obstetrics/Gynecology
Product CodePAG
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(k)
Regulation Number 878.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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