Definition: To Elevate The Fetal Head And Facilitate Delivery Of The Fetus In Women Requiring A Caesarean Section At Full Dilation Or Those Requiring A Caesarean Section After A Failed Instrumental Vaginal Delivery.
| Device Type ID | 4100 |
| Device Name | Fetal Head Elevator |
| Physical State | Inflatable Balloon Device That Provides Pressure To The Fetal Head. |
| Technical Method | Provides Pressure Via An Inflatable Balloon Inserted Into The Vaginal Canal To Elevate The Fetal Head. |
| Target Area | Vaginal Canal. |
| Regulation Description | Fetal Head Elevator. |
| 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 | 884.4350 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PWB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4100 |
| Device | Fetal Head Elevator |
| Product Code | PWB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Fetal Head Elevator. |
| CFR Regulation Number | 884.4350 [🔎] |