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FDA 510(k)

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)

K-Number: K173075 · 2018-03-08

ApplicantDxnow, Inc.
Decision Date2018-03-08
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) is a medical device manufactured by Dxnow, Inc.. It received FDA 510(k) clearance on 2018-03-08 under approval number K173075. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)?

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) is a medical device that received FDA 510(k) clearance on 2018-03-08. It is manufactured by Dxnow, Inc.. The 510(k) number is K173075.

When was ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) approved by the FDA?

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) received FDA 510(k) clearance on 2018-03-08, under approval number K173075.

What company makes ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)?

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) is manufactured by Dxnow, Inc..

What is the FDA product code for ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)?

The FDA product code for ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) is MQK.

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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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