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FDA 510(k)

Oocyte Flushing & Retrieval Medium; Gamete Buffer

K-Number: K234023 · 2024-05-10

ApplicantGimbo Medical Technology Shenzhen Co., Ltd.
Decision Date2024-05-10
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Oocyte Flushing & Retrieval Medium; Gamete Buffer is a medical device manufactured by Gimbo Medical Technology Shenzhen Co., Ltd.. It received FDA 510(k) clearance on 2024-05-10 under approval number K234023. 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 Oocyte Flushing & Retrieval Medium; Gamete Buffer?

Oocyte Flushing & Retrieval Medium; Gamete Buffer is a medical device that received FDA 510(k) clearance on 2024-05-10. It is manufactured by Gimbo Medical Technology Shenzhen Co., Ltd.. The 510(k) number is K234023.

When was Oocyte Flushing & Retrieval Medium; Gamete Buffer approved by the FDA?

Oocyte Flushing & Retrieval Medium; Gamete Buffer received FDA 510(k) clearance on 2024-05-10, under approval number K234023.

What company makes Oocyte Flushing & Retrieval Medium; Gamete Buffer?

Oocyte Flushing & Retrieval Medium; Gamete Buffer is manufactured by Gimbo Medical Technology Shenzhen Co., Ltd..

What is the FDA product code for Oocyte Flushing & Retrieval Medium; Gamete Buffer?

The FDA product code for Oocyte Flushing & Retrieval Medium; Gamete Buffer is MQL.

Related Clinical Trials

NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING NCT04213781 Interest of Audiovisual Distraction in the Management of Anxiety and Pain During Oocyte Retrieval COMPLETED

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

K242968Giftlife® Single-Step Medium Plus K240002G-Vitri™ Vitrification Straw K240149Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium 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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