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FDA 510(k)

cryo-GO Vitrification Device

K-Number: K241341 · 2024-09-26

ApplicantFujifilm Irvine Scientific
Decision Date2024-09-26
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

cryo-GO Vitrification Device is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Irvine Scientific. It received FDA 510(k) clearance on 2024-09-26 under 510(k) number K241341. 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 cryo-GO Vitrification Device?

cryo-GO Vitrification Device is a medical device that received FDA 510(k) clearance on 2024-09-26. The listed applicant is Fujifilm Irvine Scientific. The 510(k) number is K241341.

When did cryo-GO Vitrification Device receive FDA 510(k) clearance?

cryo-GO Vitrification Device received FDA 510(k) clearance on 2024-09-26, under 510(k) number K241341.

Who is the listed applicant for cryo-GO Vitrification Device?

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

What is the FDA product code for cryo-GO Vitrification Device?

The FDA product code for cryo-GO Vitrification Device is MQK.

Other records listing Fujifilm Irvine Scientific 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.

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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 ApsK240002G-Vitri™ Vitrification StrawGimbo Medical Technology Shenzhen Co., Ltd.K232980SpermAlign Sperm Separation DeviceCytoswim, Ltd.K233177Nest VT Vitrification DeviceCook Incorporated

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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