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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 a medical device manufactured by Kitazato Biopharma Co., Ltd.. It received FDA 510(k) clearance on 2016-03-14 under approval 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. It is manufactured by Kitazato Biopharma Co., Ltd.. The 510(k) number is K153027.

When was Cryotop US approved by the FDA?

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

What company makes Cryotop US?

Cryotop US is manufactured by Kitazato Biopharma Co., Ltd..

What is the FDA product code for Cryotop US?

The FDA product code for Cryotop US is MQK.

Other Devices by Kitazato Biopharma Co., Ltd.

K160864Cryotop Vitrification Kit and Cryotop Thawing Kit K160863PBS(-), Phosphate Buffered Saline K160142MINERAL OIL

Related Devices (Code: MQK)

K162051CryotecReprolife, Inc. K162640iVitri EZReprobitech Corp. K162833VitriGuardOrigio A/S 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.

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