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FDA 510(k)

INVOcell Intravaginal Culture System

K-Number: K222932 · 2023-06-22

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

Device Summary

INVOcell Intravaginal Culture System is the device name listed in this FDA 510(k) record. The listed applicant is Invo Bioscience. It received FDA 510(k) clearance on 2023-06-22 under 510(k) 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. The listed applicant is Invo Bioscience. The 510(k) number is K222932.

When did INVOcell Intravaginal Culture System receive FDA 510(k) clearance?

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

Who is the listed applicant for INVOcell Intravaginal Culture System?

The FDA 510(k) record lists Invo Bioscience as the applicant. This does not by itself establish the device manufacturer.

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

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

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.

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