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U.S. Department of Health and Human Services

Product Classification

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Device instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse
Definition Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transvaginal pelvic organ prolapse repair
Physical State Needle passers and trocars, needle guides, fixation tools, and tissue anchors used with urogynecologic surgical mesh
Technical Method Used with urogynecologic surgical mesh instrumentation to facilitate transvaginal pelvic organ prolapse repair procedures
Target Area Vagina, pelvic floor, uterus
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodePWI
Premarket Review GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.4910
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible