510(k) K222932
K222932 is an FDA 510(k) premarket notification submitted by Invo Bioscience for the device "INVOcell Intravaginal Culture System". The FDA issued a decision of Substantially Equivalent on June 22, 2023. The device falls under product code OYO (Culture, Intravaginal, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6165. Invo Bioscience has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 2023
- Date Received
- September 26, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture, Intravaginal, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6165
- Review Panel
- OB
- Submission Type
Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.