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FDA 510(k)

Giftlife® Single-Step Medium Plus

K-Number: K242968 · 2024-11-22

ApplicantGimbo Medical Technology Shenzhen Co., Ltd.
Decision Date2024-11-22
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Giftlife® Single-Step Medium Plus is the device name listed in this FDA 510(k) record. The listed applicant is Gimbo Medical Technology Shenzhen Co., Ltd.. It received FDA 510(k) clearance on 2024-11-22 under 510(k) number K242968. 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 Giftlife® Single-Step Medium Plus?

Giftlife® Single-Step Medium Plus is a medical device that received FDA 510(k) clearance on 2024-11-22. The listed applicant is Gimbo Medical Technology Shenzhen Co., Ltd.. The 510(k) number is K242968.

When did Giftlife® Single-Step Medium Plus receive FDA 510(k) clearance?

Giftlife® Single-Step Medium Plus received FDA 510(k) clearance on 2024-11-22, under 510(k) number K242968.

Who is the listed applicant for Giftlife® Single-Step Medium Plus?

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

What is the FDA product code for Giftlife® Single-Step Medium Plus?

The FDA product code for Giftlife® Single-Step Medium Plus is MQL.

Other records listing Gimbo Medical Technology Shenzhen 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.

K253121Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval NeedleK242043Sperm Freezing MediumK240002G-Vitri™ Vitrification StrawK240149Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step MediumK234023Oocyte Flushing & Retrieval Medium; Gamete BufferK232942G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media

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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

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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