FDA 510(k)

VitriGuard

K-Number: K162833 · 2017-02-16

Decision Date2017-02-16

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 2017-02-16 under approval number K162833. 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 2017-02-16. It is manufactured by Origio A/S. The 510(k) number is K162833.

When was VitriGuard approved by the FDA?

VitriGuard received FDA 510(k) clearance on 2017-02-16, under approval number K162833.

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 K180740VitriGuard K173624ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311)

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Related Devices (Code: MQK)

K162051CryotecReprolife, Inc. K153027Cryotop USKitazato Biopharma Co., Ltd. K162640iVitri EZReprobitech Corp. K181469Cryotop®US-flash and Cryotop®US-scoopKitazato Corporation K180740VitriGuardOrigio A/S K173075ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)Dxnow, Inc.

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.