Geri Embryo Incubator and Geri Dish
FDA 510(k) K171736 · Genea Biomedx Pty, Ltd.
510(k) numberK171736
Submission
- Device name
- Geri Embryo Incubator and Geri Dish
- Applicant
- Genea Biomedx Pty, Ltd.
Sydney, AU - Received
- June 12, 2017
- Decision date
- November 15, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQG – Accessory, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6120
- Specialty
- Obstetrics/Gynecology
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| K260194 | Vacuum Pump (Model: AD-VPUM-500)MQG · Traditional | Sheng Sheng Yi (Beijing) Technology Company… | 04/28/2026SE |
| K242684 | Harioculture TL-16 Time-lapse IncubatorMQG · Traditional | Hua Yue Medical Technology Co., Ltd. | 05/22/2025SE |
| K232493 | Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)MQG · Traditional | Wuhan Huchuang Union Technology Co., Ltd. | 05/07/2024SE |
| K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishMQG · Traditional | Genea Biomedx Pty, Ltd. | 06/07/2018SE |
| K173264 | EmbryoScope+MQG · Traditional | Vitrolife A/S | 05/11/2018SE |
| K180304 | Geri Embryo Incubator and Geri DishMQG · Special | Genea Biomedx Pty, Ltd. | 04/20/2018SE |
| K160753 | COOK Vacuum PumpMQG · Traditional | William A. Cook Australia Pty. , Ltd. | 06/13/2017SE |
| K160504 | RI Witness Embryology Heated PlateMQG · Traditional | Research Instruments Limited | 07/18/2016SE |
| K151357 | Miri TLMQG · Traditional | At Medical Uab | 04/22/2016SE |
More from At Medical Uab
| 510(k) | Device | Decision |
|---|---|---|
| K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishMQG · Traditional | 06/07/2018SE |
| K180304 | Geri Embryo Incubator and Geri DishMQG · Special | 04/20/2018SE |
| K170498 | Gems Oocyte Retrieval Buffer ORB-20, ORB-50MQL · Traditional | 09/28/2017SE |
| K162409 | Gems Vitrification Set, Gems Warming SetMQL · Traditional | 05/24/2017SE |
| K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst…MQL · Traditional | 05/12/2017SE |
Questions and answers
When was Geri Embryo Incubator and Geri Dish cleared by the FDA?
Geri Embryo Incubator and Geri Dish (K171736) received a 510(k) decision of Substantially Equivalent on November 15, 2017, 156 days after the submission was received.
What is the product code of K171736?
The FDA product code is MQG – Accessory, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6120.