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FDA 510(k)

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)

K-Number: K232493 · 2024-05-07

ApplicantWuhan Huchuang Union Technology Co., Ltd.
Decision Date2024-05-07
Product CodeMQG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Huchuang Union Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-07 under 510(k) number K232493. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)?

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) is a medical device that received FDA 510(k) clearance on 2024-05-07. The listed applicant is Wuhan Huchuang Union Technology Co., Ltd.. The 510(k) number is K232493.

When did Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) receive FDA 510(k) clearance?

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) received FDA 510(k) clearance on 2024-05-07, under 510(k) number K232493.

Who is the listed applicant for Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)?

The FDA 510(k) record lists Wuhan Huchuang Union Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)?

The FDA product code for Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) is MQG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07270250Impact of Dry vs Humidified Culture Conditions on Blastocyst Development and Aneuploidy: A Time-lapse Sibling Oocyte StudyRECRUITINGNCT07396181Standardization of Variable Conditions of Embryo Transfer Into the Uterine Cavity in the Procedure of Medically Assisted Procreation in HumansRECRUITINGNCT07522281Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI CyclesNOT_YET_RECRUITING

Related Devices (Code: MQG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260194Vacuum Pump (Model: AD-VPUM-500)Sheng Sheng Yi (Beijing) Technology Company LimitedK242684Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishGenea Biomedx Pty, Ltd.K173264EmbryoScope+Vitrolife A/SK180304Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd.K171736Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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