PUC · Microtools, Assisted Reproduction (Pipettes), Exempt
Obstetrics/Gynecology · 21 CFR 884.6130 · Class 2
Overview
| Product Code | PUC |
|---|---|
| Device Name | Microtools, Assisted Reproduction (Pipettes), Exempt |
| Regulation | 21 CFR 884.6130 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.
Classification Rationale
Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Special Controls
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
