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FDA 510(k)

CryoX Vitrification Freeze Kit / Thaw Kit

K-Number: K223265 · 2023-05-11

ApplicantZhejiang Horizon Medical Technology Co., Ltd.
Decision Date2023-05-11
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CryoX Vitrification Freeze Kit / Thaw Kit is a medical device manufactured by Zhejiang Horizon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-11 under approval number K223265. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CryoX Vitrification Freeze Kit / Thaw Kit?

CryoX Vitrification Freeze Kit / Thaw Kit is a medical device that received FDA 510(k) clearance on 2023-05-11. It is manufactured by Zhejiang Horizon Medical Technology Co., Ltd.. The 510(k) number is K223265.

When was CryoX Vitrification Freeze Kit / Thaw Kit approved by the FDA?

CryoX Vitrification Freeze Kit / Thaw Kit received FDA 510(k) clearance on 2023-05-11, under approval number K223265.

What company makes CryoX Vitrification Freeze Kit / Thaw Kit?

CryoX Vitrification Freeze Kit / Thaw Kit is manufactured by Zhejiang Horizon Medical Technology Co., Ltd..

What is the FDA product code for CryoX Vitrification Freeze Kit / Thaw Kit?

The FDA product code for CryoX Vitrification Freeze Kit / Thaw Kit is MQL.

Other Devices by Zhejiang Horizon Medical Technology Co., Ltd.

K232163Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle

Related Devices (Code: MQL)

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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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