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FDA 510(k)

Cryotop US

K-Number: K153027 · 2016-03-14

ApplicantKitazato Biopharma Co., Ltd.
Decision Date2016-03-14
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Cryotop US is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Biopharma Co., Ltd.. It received FDA 510(k) clearance on 2016-03-14 under 510(k) number K153027. 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 Cryotop US?

Cryotop US is a medical device that received FDA 510(k) clearance on 2016-03-14. The listed applicant is Kitazato Biopharma Co., Ltd.. The 510(k) number is K153027.

When did Cryotop US receive FDA 510(k) clearance?

Cryotop US received FDA 510(k) clearance on 2016-03-14, under 510(k) number K153027.

Who is the listed applicant for Cryotop US?

The FDA 510(k) record lists Kitazato Biopharma Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cryotop US?

The FDA product code for Cryotop US is MQK.

Other records listing Kitazato Biopharma Co., Ltd. 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.

K160864Cryotop Vitrification Kit and Cryotop Thawing KitK160863PBS(-), Phosphate Buffered SalineK160142MINERAL OIL

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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