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FDA 510(k)

iVitri EZ

K-Number: K162640 · 2017-06-30

ApplicantReprobitech Corp.
Decision Date2017-06-30
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

iVitri EZ is the device name listed in this FDA 510(k) record. The listed applicant is Reprobitech Corp.. It received FDA 510(k) clearance on 2017-06-30 under 510(k) number K162640. 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 iVitri EZ?

iVitri EZ is a medical device that received FDA 510(k) clearance on 2017-06-30. The listed applicant is Reprobitech Corp.. The 510(k) number is K162640.

When did iVitri EZ receive FDA 510(k) clearance?

iVitri EZ received FDA 510(k) clearance on 2017-06-30, under 510(k) number K162640.

Who is the listed applicant for iVitri EZ?

The FDA 510(k) record lists Reprobitech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iVitri EZ?

The FDA product code for iVitri EZ is MQK.

Other records listing Reprobitech Corp. 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.

K172751iVitri Straw

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

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

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