510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QYZClass II

At Home Intravaginal Insemination System

21 CFR 884.6110 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

QYZ is the FDA product code for At Home Intravaginal Insemination System, a class II device type, regulated under 21 CFR 884.6110. FDA's definition for this code reads: "To deliver semen to the vaginal canal for insemination". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QYZ
Device name
At Home Intravaginal Insemination System
FDA definition
To deliver semen to the vaginal canal for insemination.
Regulation
21 CFR 884.6110
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code QYZ

By decision year
3 clearances under product code QYZ with a decision year between 2023 and 2023, 2023 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code QYZ by decision year
YearClearances
20233

Applicants with the most clearances

Product code QYZ
Applicants holding the most 510(k) clearances under product code QYZ
ApplicantClearances
Hannah Life Technologies Pte, Ltd.1
Mosie Baby1
Pherdal Fertility Science, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code