| Device Type ID | 3877 |
| Device Name | Forceps, Obstetrical |
| Regulation Description | Obstetric Forceps. |
| 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 | 884.4400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HDA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3877 |
| Device | Forceps, Obstetrical |
| Product Code | HDA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Obstetric Forceps. |
| CFR Regulation Number | 884.4400 [🔎] |
| Device Problems | |
|---|---|
Break | 34 |
Detachment Of Device Component | 25 |
Difficult To Open Or Close | 11 |
Mechanical Problem | 8 |
Failure To Align | 8 |
Detachment Of Device Or Device Component | 4 |
Physical Resistance / Sticking | 2 |
Mechanical Jam | 2 |
Physical Resistance | 2 |
Jaw | 1 |
Entrapment Of Device | 1 |
| Total Device Problems | 98 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Fetzer Medical GmbH & Co. KG | II | Jan-18-2019 |