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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture, Intravaginal, Assisted Reproduction
510(k) Number K222932
Device Name INVOcell Intravaginal Culture System
Applicant
Invo Bioscience
5582 Broadcast Ct.
Sarasota,  FL  34240
Applicant Contact Steve Shum
Correspondent
Avania, LLC
100 Crowley Dr., Suite 100
Marlborough,  MA  01760
Correspondent Contact Wanda Carpinella
Regulation Number884.6165
Classification Product Code
OYO  
Date Received09/26/2022
Decision Date 06/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT05189405
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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