| Device Type ID | 3967 |
| Device Name | System, Abortion, Vacuum |
| Regulation Description | Vacuum Abortion System. |
| 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 | 884.5070 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HHI |
| 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 | 3967 |
| Device | System, Abortion, Vacuum |
| Product Code | HHI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vacuum Abortion System. |
| CFR Regulation Number | 884.5070 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GYRUS ACMI | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GYRUS ACMI, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Solder Joint Fracture | 3 |
Out-Of-Box Failure | 3 |
Pump | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Pumping Stopped | 1 |
Increase In Suction | 1 |
Overfill | 1 |
| Total Device Problems | 15 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Richard Wolf Medical Instruments Corp. | II | Aug-19-2016 |