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FDA 510(k)

EsophyX Z+ Device with SerosaFuse Fasteners and Accessories

N.º K: K240879 · 2024-04-26

SolicitanteEndogastric Solutions, Inc.
Fecha de decisión2024-04-26
Código de productoODE
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Endogastric Solutions, Inc.. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K240879. The device is classified under product code ODE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the EsophyX Z+ Device with SerosaFuse Fasteners and Accessories?

EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is Endogastric Solutions, Inc.. The 510(k) number is K240879.

When did EsophyX Z+ Device with SerosaFuse Fasteners and Accessories receive FDA 510(k) clearance?

EsophyX Z+ Device with SerosaFuse Fasteners and Accessories received FDA 510(k) clearance on 2024-04-26, under 510(k) number K240879.

Who is the listed applicant for EsophyX Z+ Device with SerosaFuse Fasteners and Accessories?

The FDA 510(k) record lists Endogastric Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EsophyX Z+ Device with SerosaFuse Fasteners and Accessories?

The FDA product code for EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is ODE.

Ensayos clínicos relacionados

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Otros registros que enlistan a Endogastric Solutions, Inc. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K172811EsophyX Z, EsophyX2 HDK171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and AccessoriesK160960EsophyX® Z Device with SerosaFuse Fasteners and Accessories

Dispositivos relacionados (Código: ODE)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K233240GERDX-SystemG-Surg GmbHK172811EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc.K171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.K160960EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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