PNU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5210
- Medical specialty
- Obstetrics/Gynecology
- FDA definition
- Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Hem-Avert Perianal Stabilizer (DEN160005) | Stetrix, Inc. | 2016-12-19 |
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