FDA 510(k)

ORTIV (ORTIV-BL, ORTIV-WH)

N.º K: K241646 · 2024-11-01

Fecha de decisión2024-11-01

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ORTIV (ORTIV-BL, ORTIV-WH) is the device name listed in this FDA 510(k) record. The listed applicant is Mvitro Co., Ltd.. It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K241646. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ORTIV (ORTIV-BL, ORTIV-WH)?

ORTIV (ORTIV-BL, ORTIV-WH) is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is Mvitro Co., Ltd.. The 510(k) number is K241646.

When did ORTIV (ORTIV-BL, ORTIV-WH) receive FDA 510(k) clearance?

ORTIV (ORTIV-BL, ORTIV-WH) received FDA 510(k) clearance on 2024-11-01, under 510(k) number K241646.

Who is the listed applicant for ORTIV (ORTIV-BL, ORTIV-WH)?

The FDA 510(k) record lists Mvitro Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTIV (ORTIV-BL, ORTIV-WH)?

The FDA product code for ORTIV (ORTIV-BL, ORTIV-WH) is GEX. This falls under the Gastroenterology category.

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Fuente oficial

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