Cleared Special

Geri Embryo Incubator and Geri Dish

K180304 · Genea Biomedx Pty, Ltd. · Obstetrics & Gynecology
Apr 2018
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K180304 is an FDA 510(k) clearance for the Geri Embryo Incubator and Geri Dish, a Accessory, Assisted Reproduction (Class II — Special Controls, product code MQG), submitted by Genea Biomedx Pty, Ltd. (Sydney, AU). The FDA issued a Cleared decision on April 20, 2018, 77 days after receiving the submission on February 2, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6120.

Submission Details

510(k) Number K180304 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2018
Decision Date April 20, 2018
Days to Decision 77 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQG — Accessory, Assisted Reproduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6120

Similar Devices — MQG Accessory, Assisted Reproduction

All 44
Harioculture TL-16 Time-lapse Incubator
K242684 · Hua Yue Medical Technology Co., Ltd. · May 2025
Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
K232493 · Wuhan Huchuang Union Technology Co., Ltd. · May 2024
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
K180188 · Genea Biomedx Pty, Ltd. · Jun 2018
EmbryoScope+
K173264 · Vitrolife A/S · May 2018
Geri Embryo Incubator and Geri Dish
K171736 · Genea Biomedx Pty, Ltd. · Nov 2017
COOK Vacuum Pump
K160753 · William A. Cook Australia Pty. , Ltd. · Jun 2017