• 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 intrauterine tamponade balloon
Regulation Description Obstetric-gynecologic specialized manual instrument.
Definition Provides temporary control or reduction of postpartum uterine bleeding.
Physical State The device consists of a catheter with a balloon at the distal end. The balloon is distended to achieve tamponade or reduction of post partum uterine bleeding.
Technical Method The clinician passes the balloon through the vagina and cervix into the uterus. Then, he/she distends the balloon and closely monitors the patient's bleeding.
Target Area uterus, cervix, vagina
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeOQY
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
-
-