Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INVOcell Intravaginal Culture System

K-Number: K222932 · 2023-06-22

Decision Date2023-06-22
Product CodeOYO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INVOcell Intravaginal Culture System is a medical device manufactured by Invo Bioscience. It received FDA 510(k) clearance on 2023-06-22 under approval number K222932. The device is classified under product code OYO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INVOcell Intravaginal Culture System?

INVOcell Intravaginal Culture System is a medical device that received FDA 510(k) clearance on 2023-06-22. It is manufactured by Invo Bioscience. The 510(k) number is K222932.

When was INVOcell Intravaginal Culture System approved by the FDA?

INVOcell Intravaginal Culture System received FDA 510(k) clearance on 2023-06-22, under approval number K222932.

What company makes INVOcell Intravaginal Culture System?

INVOcell Intravaginal Culture System is manufactured by Invo Bioscience.

What is the FDA product code for INVOcell Intravaginal Culture System?

The FDA product code for INVOcell Intravaginal Culture System is OYO.

Related Clinical Trials

Related PubMed Literature

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.