| Device Type ID | 4027 |
| Device Name | Microtools, Assisted Reproduction (pipettes) |
| Regulation Description | Assisted Reproduction Microtools. |
| 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 | 884.6130 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MQH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 4027 |
| Device | Microtools, Assisted Reproduction (pipettes) |
| Product Code | MQH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Assisted Reproduction Microtools. |
| CFR Regulation Number | 884.6130 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
LIFEGLOBAL GROUP, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RESEARCH INSTRUMENTS LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RESEARCH INSTRUMENTS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 1 |
Material Fragmentation | 1 |
Insufficient Information | 1 |
| Total Device Problems | 3 |