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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 the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Horizon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-11 under 510(k) 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. The listed applicant is Zhejiang Horizon Medical Technology Co., Ltd.. The 510(k) number is K223265.

When did CryoX Vitrification Freeze Kit / Thaw Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for CryoX Vitrification Freeze Kit / Thaw Kit?

The FDA 510(k) record lists Zhejiang Horizon Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Zhejiang Horizon Medical Technology 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.

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

Related Devices (Code: MQL)

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.

K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato CorporationK242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NV

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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