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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 the device name listed in this FDA 510(k) record. The listed applicant is Origio A/S. It received FDA 510(k) clearance on 2020-06-25 under 510(k) 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. The listed applicant is Origio A/S. The 510(k) number is K200815.

When did VitriGuard receive FDA 510(k) clearance?

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

Who is the listed applicant for VitriGuard?

The FDA 510(k) record lists Origio A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitriGuard?

The FDA product code for VitriGuard is MQK.

Other records listing Origio A/S as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180740VitriGuardK173624ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)K172197SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPSK161547Transem and EchoGen Embryo Transfer CathetersK162833VitriGuardK153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash

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Related Devices (Code: MQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241626SperSort™ Sperm Sorting Chip (IPG02)Ipreg IncorporationK241454Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)Guangzhou Hehong Biotech Co., Ltd.K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount ApsK241341cryo-GO Vitrification DeviceFujifilm Irvine ScientificK240002G-Vitri™ Vitrification StrawGimbo Medical Technology Shenzhen Co., Ltd.K232980SpermAlign Sperm Separation DeviceCytoswim, Ltd.

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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