Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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 2024-05-10 under 510(k) 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. The listed applicant is Gimbo Medical Technology Shenzhen Co., Ltd.. The 510(k) number is K234023.

When did Oocyte Flushing & Retrieval Medium; Gamete Buffer receive FDA 510(k) clearance?

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

Who is the listed applicant for Oocyte Flushing & Retrieval Medium; Gamete Buffer?

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 Oocyte Flushing & Retrieval Medium; Gamete Buffer?

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

Related Clinical Trials

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.

NCT07522281Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI CyclesNOT_YET_RECRUITING

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 MediumK242968Giftlife® Single-Step Medium PlusK240002G-Vitri™ Vitrification StrawK240149Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step MediumK232942G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media

View all 7 devices →

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.

↑