FDA 510(k)

EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories

N.º K: K171307 · 2017-06-22

Fecha de decisión2017-06-22

Código de productoODE

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, 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 2017-06-22 under 510(k) number K171307. 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 EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories?

EsophyX2 HD 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 2017-06-22. The listed applicant is Endogastric Solutions, Inc.. The 510(k) number is K171307.

When did EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories receive FDA 510(k) clearance?

EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories received FDA 510(k) clearance on 2017-06-22, under 510(k) number K171307.

Who is the listed applicant for EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, 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 EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories?

The FDA product code for EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories is ODE.

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

K240879EsophyX Z+ Device with SerosaFuse Fasteners and Accessories K172811EsophyX Z, EsophyX2 HD K160960EsophyX® Z Device with SerosaFuse Fasteners and Accessories

Dispositivos relacionados (Código: ODE)

K233240GERDX-SystemG-Surg GmbH K240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.K172811EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc.K160960EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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