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U.S. Department of Health and Human Services

Product Classification

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Device instrumentation, surgical mesh, urogynecologic, stress urinary incontinence
Regulation Description Specialized surgical instrumentation for use with urogynecologic surgical mesh.
Definition Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence
Physical State Needle passers and trocars, needle guides, fixation tools, and tissue anchors used with surgical mesh.
Technical Method Used with urogynecologic surgical mesh instrumentation to facilitate stress urinary incontinence procedures
Target Area Urethra, vagina, pelvic floor
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodePWJ
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 884.4910
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible