meddevicedb.com FDA Device Reference

GI Genius

DEN200055 Class II Direct
Decision Date
2021-04-09
Sponsor / Applicant
Cosmo Artificial Intelligence - Ai, Ltd.

Technical Specification

510(k) Submission ID DEN200055
Product Code QNP
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.1520
Decision Date 2021-04-09
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

GI Genius received FDA 510(k) clearance under submission number DEN200055, sponsored by Cosmo Artificial Intelligence - Ai, Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2021-04-09.

Classification & Regulation

This clearance is catalogued under FDA product code QNP and 21 CFR 876.1520, within the Gastroenterology, Urology review panel as a Class II device.