QYZ · At Home Intravaginal Insemination System
Obstetrics/Gynecology · 21 CFR 884.6110 · Class 2
Overview
| Product Code | QYZ |
|---|---|
| Device Name | At Home Intravaginal Insemination System |
| Regulation | 21 CFR 884.6110 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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.
Classification Rationale
Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
Special Controls
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232579 | Twoplus Applicator | Hannah Life Technologies Pte , Ltd. | Dec 21, 2023 | SESE |
| K231645 | PherDal® At-Home Insemination Kit | Pherdal Fertility Science, Inc. | Dec 14, 2023 | SESE |
| K231203 | Mosie Baby Kit | Mosie Baby | Nov 29, 2023 | SESE |
Top Applicants
- Pherdal Fertility Science, Inc. — 1 clearance
- Mosie Baby — 1 clearance
- Hannah Life Technologies Pte , Ltd. — 1 clearance
