FDA 510(k)

G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media

N.º K: K232942 · 2024-01-30

SolicitanteGimbo Medical Technology Shenzhen Co., Ltd.

Fecha de decisión2024-01-30

Código de productoMQL

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media 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 2024-01-30 under 510(k) number K232942. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media?

G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media is a medical device that received FDA 510(k) clearance on 2024-01-30. The listed applicant is Gimbo Medical Technology Shenzhen Co., Ltd.. The 510(k) number is K232942.

When did G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media receive FDA 510(k) clearance?

G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media received FDA 510(k) clearance on 2024-01-30, under 510(k) number K232942.

Who is the listed applicant for G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media?

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 Freeze Media; G-Vitri™ Vitrification Thawing Media?

The FDA product code for G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media is MQL.

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Otros registros que enlistan a Gimbo Medical Technology Shenzhen Co., Ltd. como solicitante

K253121Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle K242043Sperm Freezing Medium 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

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Dispositivos relacionados (Código: MQL)

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato Corporation K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin 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 Corporation

Fuente oficial

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