Product code PNU
- Device name
- Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.5210
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery
- Source
- FDA openFDA device classification dataset