meddevicedb.com FDA Device Reference

INVOcell

DEN150008 Class II Direct
Decision Date
2015-11-02
Sponsor / Applicant
Invo Bioscience

Technical Specification

510(k) Submission ID DEN150008
Product Code OYO
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.6165
Decision Date 2015-11-02
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

INVOcell received FDA 510(k) clearance under submission number DEN150008, sponsored by Invo Bioscience. The device was reviewed via the Direct premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2015-11-02.

Classification & Regulation

This clearance is catalogued under FDA product code OYO and 21 CFR 884.6165, within the Obstetrics/Gynecology review panel as a Class II device.