EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
Device Facts
| Record ID | K000950 |
|---|---|
| Device Name | EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201 |
| Applicant | Labotect Labor-Technik Gottingen |
| Product Code | MQF · Obstetrics/Gynecology |
| Decision Date | May 12, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.6110 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.
Special Controls
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
