Definition: Designed To Provide Counter-pressure To The Perianal Region During Vaginal Childbirth To Help Reduce The Likelihood Of Cesarean Delivery
| Device Type ID | 4085 |
| Device Name | Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery |
| Physical State | External Device That Provides Counter Pressure To Peri-anal Region |
| Technical Method | Provide Counter-pressure To The Perianal Region During Vaginal Childbirth |
| Target Area | Perianal Region |
| Regulation Description | Pressure Wedge For The Reduction Of Cesarean Delivery. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.5210 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PNU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4085 |
| Device | Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery |
| Product Code | PNU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Pressure Wedge For The Reduction Of Cesarean Delivery. |
| CFR Regulation Number | 884.5210 [🔎] |