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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 Gastroenterology/Urology
Product CodePWJ
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
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
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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