EmbryoScope+

FDA 510(k) K173264 · Vitrolife A/S

Substantially Equivalent

510(k) numberK173264

Submission

Device name
EmbryoScope+
Applicant
Vitrolife A/S
Viby J, DK
Received
October 11, 2017
Decision date
May 11, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQG – Accessory, Assisted Reproduction
Device class
Class II (moderate risk)
Regulation
21 CFR 884.6120
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code MQG

510(k)DeviceApplicantDecision
K261083Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum…MQG · Traditional CooperSurgical, Inc.08/19/2026SE
K260194Vacuum Pump (Model: AD-VPUM-500)MQG · Traditional Sheng Sheng Yi (Beijing) Technology Company…04/28/2026SE
K242684Harioculture TL-16 Time-lapse IncubatorMQG · Traditional Hua Yue Medical Technology Co., Ltd.05/22/2025SE
K232493Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)MQG · Traditional Wuhan Huchuang Union Technology Co., Ltd.05/07/2024SE
K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishMQG · Traditional Genea Biomedx Pty, Ltd.06/07/2018SE
K180304Geri Embryo Incubator and Geri DishMQG · Special Genea Biomedx Pty, Ltd.04/20/2018SE
K171736Geri Embryo Incubator and Geri DishMQG · Traditional Genea Biomedx Pty, Ltd.11/15/2017SE
K160753COOK Vacuum PumpMQG · Traditional William A. Cook Australia Pty. , Ltd.06/13/2017SE
K160504RI Witness Embryology Heated PlateMQG · Traditional Research Instruments Limited07/18/2016SE
K151357Miri TLMQG · Traditional At Medical Uab04/22/2016SE

More from At Medical Uab

510(k)DeviceDecision
K213869EmbryoSlide+ ic8 dishMQK · Traditional 03/11/2022SE
K182798KIDScore D3PBH · Traditional 07/19/2019SE
K150961EmbryoSlide Culture DishMQK · Traditional 12/04/2015SE

Questions and answers

When was EmbryoScope+ cleared by the FDA?

EmbryoScope+ (K173264) received a 510(k) decision of Substantially Equivalent on May 11, 2018, 212 days after the submission was received.

What is the product code of K173264?

The FDA product code is MQG – Accessory, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6120.