| Device Type ID | 4024 |
| Device Name | Needle, Assisted Reproduction |
| Regulation Description | Assisted Reproduction Needles. |
| 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 | 884.6100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MQE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 4024 |
| Device | Needle, Assisted Reproduction |
| Product Code | MQE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Assisted Reproduction Needles. |
| CFR Regulation Number | 884.6100 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
KITAZATO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VITROLIFE AB | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VITROLIFE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
WILLIAM A. COOK AUSTRALIA PTY, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILLIAM COOK | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Dull, Blunt | 15 |
Physical Property Issue | 2 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 20 |