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FDA 510(k)

Sperm Freezing Medium

K-Number: K242043 · 2025-01-08

ApplicantGimbo Medical Technology Shenzhen Co., Ltd.
Decision Date2025-01-08
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sperm Freezing Medium is a medical device manufactured by Gimbo Medical Technology Shenzhen Co., Ltd.. It received FDA 510(k) clearance on 2025-01-08 under approval number K242043. 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 Sperm Freezing Medium?

Sperm Freezing Medium is a medical device that received FDA 510(k) clearance on 2025-01-08. It is manufactured by Gimbo Medical Technology Shenzhen Co., Ltd.. The 510(k) number is K242043.

When was Sperm Freezing Medium approved by the FDA?

Sperm Freezing Medium received FDA 510(k) clearance on 2025-01-08, under approval number K242043.

What company makes Sperm Freezing Medium?

Sperm Freezing Medium is manufactured by Gimbo Medical Technology Shenzhen Co., Ltd..

What is the FDA product code for Sperm Freezing Medium?

The FDA product code for Sperm Freezing Medium is MQL.

Related Clinical Trials

NCT06238570 Validation of Donor Oocytes Semi-automated Vitrification RECRUITING NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING

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 K234023Oocyte Flushing & Retrieval Medium; Gamete Buffer K232942G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media

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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