DeviceClearance

Product code PNU— Obstetrics/Gynecology

Hem-Avert Perianal Stabilizer

Classification name
Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
Device class
Class 2
Regulation
21 CFR 884.5210
Advisory panel
Obstetrics/Gynecology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery”

— U.S. Food and Drug Administration, device classification record for product code PNU under 21 CFR 884.5210, via openFDA

Market context for product code PNU

FDA has cleared 1 device under product code PNU, all in 2016, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PNU

Recent clearances under product code PNU

Data sourced from openFDA. This site is unofficial and independent of the FDA.