FDA 510(k)

Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)

N.º K: K261068 · 2026-06-30

Fecha de decisión2026-06-30

Código de productoGEH

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) is the device name listed in this FDA 510(k) record. The listed applicant is Serpex Medical. It received FDA 510(k) clearance on 2026-06-30 under 510(k) number K261068. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)?

Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) is a medical device that received FDA 510(k) clearance on 2026-06-30. The listed applicant is Serpex Medical. The 510(k) number is K261068.

When did Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) receive FDA 510(k) clearance?

Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) received FDA 510(k) clearance on 2026-06-30, under 510(k) number K261068.

Who is the listed applicant for Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)?

The FDA 510(k) record lists Serpex Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)?

The FDA product code for Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) is GEH.

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Otros registros que enlistan a Serpex Medical como solicitante

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)

Dispositivos relacionados (Código: GEH)

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH K252198Remover de Manchas de Crioterapia Avanzado (Remover de Manchas de Piel Avanzado)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.

Fuente oficial

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