MQI · Microtool Fabrication, Assisted Reproduction
Obstetrics/Gynecology · 21 CFR 884.6140 · Class 2
Overview
| Product Code | MQI |
|---|---|
| Device Name | Microtool Fabrication, Assisted Reproduction |
| Regulation | 21 CFR 884.6140 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
Assisted reproduction micropipette fabrication devices are instruments intended to pull, bevel, or forge a micropipette or needle for intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) or other similar assisted reproduction procedures.
Classification Rationale
Class II (special controls) (design specifications, labeling requirements, and clinical testing).
Special Controls
*Classification.* Class II (special controls) (design specifications, labeling requirements, and clinical testing).
Cleared Devices (0)
No cleared devices on record.
