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U.S. Department of Health and Human Services

Product Classification

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Device mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Regulation Description Surgical mesh.
Definition Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility.
Physical State 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 mesh to desired size and shap
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 CodeOTN
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
Guidance Document
  • Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070852.htm] 
Third Party Review Not Third Party Eligible
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