DeviceClearance

Product code QYZ— Obstetrics/Gynecology

Mosie Baby Kit

Classification name
At Home Intravaginal Insemination System
Device class
Class 2
Regulation
21 CFR 884.6110
Advisory panel
Obstetrics/Gynecology
Total cleared
3
First cleared
Most recent

FDA classification definition

“To deliver semen to the vaginal canal for insemination.”

— U.S. Food and Drug Administration, device classification record for product code QYZ under 21 CFR 884.6110, via openFDA

Market context for product code QYZ

FDA has cleared 3 devices under product code QYZ, all in 2023, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QYZ

Recent clearances under product code QYZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.