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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 a medical device manufactured by Gimbo Medical Technology Shenzhen Co., Ltd.. It received FDA 510(k) clearance on 2024-11-22 under approval 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. It is manufactured by Gimbo Medical Technology Shenzhen Co., Ltd.. The 510(k) number is K242968.

When was Giftlife® Single-Step Medium Plus approved by the FDA?

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

What company makes Giftlife® Single-Step Medium Plus?

Giftlife® Single-Step Medium Plus is manufactured by Gimbo Medical Technology Shenzhen Co., Ltd..

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

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

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Other Devices by Gimbo Medical Technology Shenzhen Co., Ltd.

K240002G-Vitri™ Vitrification Straw K240149Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium K234023Oocyte Flushing & Retrieval Medium; Gamete Buffer K232942G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media K242043Sperm Freezing Medium

Related Devices (Code: MQL)

K160864Cryotop Vitrification Kit and Cryotop Thawing KitKitazato Biopharma Co., Ltd. K153478Sydney IVF Gamete BufferWilliam A. Cook Australia Pty. , Ltd. K160863PBS(-), Phosphate Buffered SalineKitazato Biopharma Co., Ltd. K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashOrigio A/S K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing KitWilliam A. Cook Australia Pty. , Ltd. K152682Sydney IVF Cryopreservation Kit, Sydney IVF Thawing KitWillian A. Cook Australia Pty, Ltd.

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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