Cleared Traditional

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

K232493 · Wuhan Huchuang Union Technology Co., Ltd. · Obstetrics & Gynecology

May 2024

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K232493 is an FDA 510(k) clearance for the Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004), a Accessory, Assisted Reproduction (Class II — Special Controls, product code MQG), submitted by Wuhan Huchuang Union Technology Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on May 7, 2024, 264 days after receiving the submission on August 17, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6120.

Submission Details

510(k) Number	K232493 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 17, 2023
Decision Date	May 07, 2024
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF