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FDA 510(k)

VitriGuard

K-Number: K200815 · 2020-06-25

ApplicantOrigio A/S
Decision Date2020-06-25
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VitriGuard is a medical device manufactured by Origio A/S. It received FDA 510(k) clearance on 2020-06-25 under approval number K200815. 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 VitriGuard?

VitriGuard is a medical device that received FDA 510(k) clearance on 2020-06-25. It is manufactured by Origio A/S. The 510(k) number is K200815.

When was VitriGuard approved by the FDA?

VitriGuard received FDA 510(k) clearance on 2020-06-25, under approval number K200815.

What company makes VitriGuard?

VitriGuard is manufactured by Origio A/S.

What is the FDA product code for VitriGuard?

The FDA product code for VitriGuard is MQK.

Other Devices by Origio A/S

K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash K152932BlastGen K172197SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS K161547Transem and EchoGen Embryo Transfer Catheters K162833VitriGuard K180740VitriGuard

View all 8 devices →

Related Devices (Code: MQK)

K162051CryotecReprolife, Inc. K153027Cryotop USKitazato Biopharma Co., Ltd. K162640iVitri EZReprobitech Corp. K162833VitriGuardOrigio A/S K181469Cryotop®US-flash and Cryotop®US-scoopKitazato Corporation K180740VitriGuardOrigio A/S

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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