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U.S. Department of Health and Human Services

Product Classification

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Device pressure wedge, perianal, for reduction of cesarean delivery
Regulation Description Pressure wedge for the reduction of cesarean delivery.
Definition Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery
Physical State External device that provides counter pressure to peri-anal region
Technical Method Provide counter-pressure to the perianal region during vaginal childbirth
Target Area Perianal region
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodePNU
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.5210
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