QYZ

At Home Intravaginal Insemination System

Product code
QYZ
Device name
At Home Intravaginal Insemination System
Device class
Class 2
21 CFR
21 CFR 884.6110
Medical specialty
Obstetrics/Gynecology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
3
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
3 (all years; only the last 3 years are listed here)

FDA classification definition

To deliver semen to the vaginal canal for insemination.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2023-12-21.

NumberDecision dateApplicantDevice nameSummary
K2325792023-12-21Hannah Life Technologies Pte , Ltd.Twoplus Applicator
K2316452023-12-14Pherdal Fertility Science, Inc.PherDal® At-Home Insemination KitPDF
K2312032023-11-29Mosie BabyMosie Baby KitPDF

2 summaries are archived here for direct download.

Official FDA classification page: QYZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).