INVOcell Intravaginal Culture System— 510(k) K222932

Name: FDA 510(k) clearance K222932
Creator: U.S. Food and Drug Administration
Published: 2023-06-22

Substantially Equivalent

Invo Bioscience

FDA 510(k) clearance K222932 for INVOcell Intravaginal Culture System, Substantially Equivalent on 2023-06-22. Applicant: Invo Bioscience. Device class: 2.

Clearance details

Applicant: Invo Bioscience
Product code: Code OYO
Device class: Class 2
Regulation: 21 CFR 884.6165
Advisory panel: Obstetrics/Gynecology
Date received: 2022-09-26
Decision date: 2023-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OYO

view all

DEN150008 — INVOcell2015-11-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.