Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart G — Assisted Reproduction Devices](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices) → [21 CFR 884.6110](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/884.6110) → QYZ — At Home Intravaginal Insemination System

# QYZ · At Home Intravaginal Insemination System

_Obstetrics/Gynecology · 21 CFR 884.6110 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/QYZ

## Overview

- **Product Code:** QYZ
- **Device Name:** At Home Intravaginal Insemination System
- **Regulation:** [21 CFR 884.6110](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/884.6110)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## 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).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K232579](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/QYZ/K232579.md) | Twoplus Applicator | Hannah Life Technologies Pte , Ltd. | Dec 21, 2023 | SESE |
| [K231645](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/QYZ/K231645.md) | PherDal® At-Home Insemination Kit | Pherdal Fertility Science, Inc. | Dec 14, 2023 | SESE |
| [K231203](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/QYZ/K231203.md) | Mosie Baby Kit | Mosie Baby | Nov 29, 2023 | SESE |

## Top Applicants

- Hannah Life Technologies Pte , Ltd. — 1 clearance
- Mosie Baby — 1 clearance
- Pherdal Fertility Science, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/QYZ](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/QYZ)

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