Culture, Intravaginal, Assisted Reproduction
The Culture, Intravaginal, Assisted Reproduction device is used for the intravaginal culture of human gametes and embryos, holding and maintaining gametes and developing embryos over the duration of the intravaginal culture period as part of assisted reproductive technology (ART). It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OYO, with regulation number 884.6165 under the Obstetrics/Gynecology medical specialty.
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Basic Information
- Product Code
- OYO
- Device Class
- FDA class 2
- Regulation Number
- 884.6165
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.