| Device Type ID | 4026 |
| Device Name | Accessory, Assisted Reproduction |
| Regulation Description | Assisted Reproduction Accessories. |
| 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 | 884.6120 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MQG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 4026 |
| Device | Accessory, Assisted Reproduction |
| Product Code | MQG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Assisted Reproduction Accessories. |
| CFR Regulation Number | 884.6120 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AT MEDICAL UAB | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORIGIO, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
UNISENSE FERTILITECH A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VITROLIFE A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cook Inc. | II | Apr-19-2018 |
| 2 | Cook Inc. | II | Apr-13-2018 |