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FDA 510(k)

Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)

K-Number: K233477 · 2024-07-01

ApplicantShandong Wego Ruisheng Medical Device Co., Ltd.
Decision Date2024-07-01
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) is a medical device manufactured by Shandong Wego Ruisheng Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2024-07-01 under approval number K233477. 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 Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)?

Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) is a medical device that received FDA 510(k) clearance on 2024-07-01. It is manufactured by Shandong Wego Ruisheng Medical Device Co., Ltd.. The 510(k) number is K233477.

When was Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) approved by the FDA?

Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) received FDA 510(k) clearance on 2024-07-01, under approval number K233477.

What company makes Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)?

Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) is manufactured by Shandong Wego Ruisheng Medical Device Co., Ltd..

What is the FDA product code for Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)?

The FDA product code for Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) is MQL.

Related Clinical Trials

NCT06238570 Validation of Donor Oocytes Semi-automated Vitrification RECRUITING

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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