| Device Type ID | 3878 |
| Device Name | Extractor, Vacuum, Fetal |
| Regulation Description | Fetal Vacuum Extractor. |
| 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 | 884.4340 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HDB |
| 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 | 3878 |
| Device | Extractor, Vacuum, Fetal |
| Product Code | HDB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Fetal Vacuum Extractor. |
| CFR Regulation Number | 884.4340 [🔎] |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 3 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Appropriate Term/Code Not Available | 1 |
Insufficient Information | 1 |
| Total Device Problems | 6 |