| Device Type ID | 3946 |
| Device Name | Amniotome |
| Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
| 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) Exempt |
| CFR Regulation Number | 884.4530 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HGE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3946 |
| Device | Amniotome |
| Product Code | HGE |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Obstetric-gynecologic Specialized Manual Instrument. |
| CFR Regulation Number | 884.4530 [🔎] |