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U.S. Department of Health and Human Services

Product Classification

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Device fixation, non-absorbable or absorbable, for pelvic use
Regulation Description Obstetric-gynecologic specialized manual instrument.
Definition Attaching suture or stapling ligaments of the pelvic floor.
Physical State non-absorbable or absorbable suture or staple; may include instruments and/or tissue anchoring components as part of a kit
Technical Method provides mechanism for attachment to and/or from ligaments of the pelvic floor
Target Area uterus, vagina, pelvic floor
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodePBQ
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.4530
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible