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FDA 510(k)

Transem and EchoGen Embryo Transfer Catheters

K-Number: K161547 · 2017-03-09

ApplicantOrigio A/S
Decision Date2017-03-09
Product CodeMQF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Transem and EchoGen Embryo Transfer Catheters is a medical device manufactured by Origio A/S. It received FDA 510(k) clearance on 2017-03-09 under approval number K161547. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transem and EchoGen Embryo Transfer Catheters?

Transem and EchoGen Embryo Transfer Catheters is a medical device that received FDA 510(k) clearance on 2017-03-09. It is manufactured by Origio A/S. The 510(k) number is K161547.

When was Transem and EchoGen Embryo Transfer Catheters approved by the FDA?

Transem and EchoGen Embryo Transfer Catheters received FDA 510(k) clearance on 2017-03-09, under approval number K161547.

What company makes Transem and EchoGen Embryo Transfer Catheters?

Transem and EchoGen Embryo Transfer Catheters is manufactured by Origio A/S.

What is the FDA product code for Transem and EchoGen Embryo Transfer Catheters?

The FDA product code for Transem and EchoGen Embryo Transfer Catheters is MQF.

Related Clinical Trials

NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING NCT07396181 Standardization of Variable Conditions of Embryo Transfer Into the Uterine Cavity in the Procedure of Medically Assisted Procreation in Humans RECRUITING

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Related Devices (Code: MQF)

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Official Source

View on FDA Database →

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

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