• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
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 Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(k)
Regulation Number 884.4530
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-