INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES
Device Facts
| Record ID | K072600 |
|---|---|
| Device Name | INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES |
| Applicant | Sunlight Medical, Inc. |
| Product Code | MQH · Obstetrics/Gynecology |
| Decision Date | May 19, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.6130 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
