PNU — Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery Class II
FDA product code PNU covers "Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery", a Class II medical device regulated under 21 CFR 884.5210. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PNU
- Device Class
- Class II
- Regulation Number
- 884.5210
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN160005 | stetrix | Hem-Avert Perianal Stabilizer | December 19, 2016 |