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510(k) K232493

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) by Wuhan Huchuang Union Technology Co., Ltd. — Product Code MQG

K232493 is an FDA 510(k) premarket notification submitted by Wuhan Huchuang Union Technology Co., Ltd. for the device "Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)". The FDA issued a decision of Substantially Equivalent on May 7, 2024. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2024
Date Received
August 17, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6120
Review Panel
OB
Submission Type

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  • K180188 — Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish (June 7, 2018)
  • K173264 — EmbryoScope+ (May 11, 2018)
  • K180304 — Geri Embryo Incubator and Geri Dish (April 20, 2018)
  • K171736 — Geri Embryo Incubator and Geri Dish (November 15, 2017)
  • K160753 — COOK Vacuum Pump (June 13, 2017)
  • K160504 — RI Witness Embryology Heated Plate (July 18, 2016)
  • K151357 — MIRI TL (April 22, 2016)
  • K133712 — EMBRYOVIEWER SOFTWARE (August 8, 2014)

FDA data resources