PNU · Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
Obstetrics/Gynecology · 21 CFR 884.5210 · Class 2
Overview
| Product Code | PNU |
|---|---|
| Device Name | Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery |
| Regulation | 21 CFR 884.5210 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
A pressure wedge for the reduction of cesarean delivery is a prescription device that provides external mechanical support to the perianal region during the labor and vaginal delivery process. External mechanical support of the perianal region is intended to help reduce the occurrence of cesarean delivery.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
In combination with the general controls of the FD&C Act, the Pressure wedge for the reduction of cesarean delivery is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) The patient contacting materials must be evaluated to be biocompatible. (2) Nonclinical performance data must demonstrate that the device will not break when subjected to the forces it will be exposed to during labor. (3) Performance data must validate the sterility of the device. (4) Performance data must support the shelf life of the device by demonstrating continued sterility and package integrity over the labeled shelf life. (5) Clinical performance data must be provided that characterizes the rate of skin/tissue trauma. (6) The labeling must include: (i) Specific instructions regarding the proper placement and use of the device. (ii) A shelf life.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN160005 | Hem-Avert Perianal Stabilizer | Stetrix, Inc. | Dec 19, 2016 | DENG |
Top Applicants
- Stetrix, Inc. — 1 clearance
