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

Culture, Intravaginal, Assisted Reproduction

21 CFR 884.6165 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

OYO is the FDA product code for Culture, Intravaginal, Assisted Reproduction, a class II device type, regulated under 21 CFR 884.6165. FDA's definition for this code reads: "Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OYO
Device name
Culture, Intravaginal, Assisted Reproduction
FDA definition
Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.
Regulation
21 CFR 884.6165
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
2
Ingested recalls
0

Clearances, product code OYO

By decision year
2 clearances under product code OYO with a decision year between 2015 and 2023, 2015 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OYO by decision year
YearClearances
20151
20231

Applicants with the most clearances

Product code OYO
Applicants holding the most 510(k) clearances under product code OYO
ApplicantClearances
Invo Bioscience2

Companies listing this code with FDA

Companies whose registered establishments list this code