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FDA 510(k)

G-Vitri™ Vitrification Straw

K-Number: K240002 · 2024-06-14

ApplicantGimbo Medical Technology Shenzhen Co., Ltd.
Decision Date2024-06-14
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

G-Vitri™ Vitrification Straw 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 2024-06-14 under 510(k) number K240002. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G-Vitri™ Vitrification Straw?

G-Vitri™ Vitrification Straw is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Gimbo Medical Technology Shenzhen Co., Ltd.. The 510(k) number is K240002.

When did G-Vitri™ Vitrification Straw receive FDA 510(k) clearance?

G-Vitri™ Vitrification Straw received FDA 510(k) clearance on 2024-06-14, under 510(k) number K240002.

Who is the listed applicant for G-Vitri™ Vitrification Straw?

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 G-Vitri™ Vitrification Straw?

The FDA product code for G-Vitri™ Vitrification Straw is MQK.

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 PlusK240149Giftlife™ 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: MQK)

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.

K241626SperSort™ Sperm Sorting Chip (IPG02)Ipreg IncorporationK241454Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)Guangzhou Hehong Biotech Co., Ltd.K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount ApsK241341cryo-GO Vitrification DeviceFujifilm Irvine ScientificK232980SpermAlign Sperm Separation DeviceCytoswim, Ltd.K233177Nest VT Vitrification DeviceCook Incorporated

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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