FDA 510(k)

Auris Robotic Endoscopy System (ARES)

N.º K: K152319 · 2016-05-26

SolicitanteAuris Surgical Robotics, Inc.

Fecha de decisión2016-05-26

Código de productoEOQ

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Auris Robotic Endoscopy System (ARES) is the device name listed in this FDA 510(k) record. The listed applicant is Auris Surgical Robotics, Inc.. It received FDA 510(k) clearance on 2016-05-26 under 510(k) number K152319. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Auris Robotic Endoscopy System (ARES)?

Auris Robotic Endoscopy System (ARES) is a medical device that received FDA 510(k) clearance on 2016-05-26. The listed applicant is Auris Surgical Robotics, Inc.. The 510(k) number is K152319.

When did Auris Robotic Endoscopy System (ARES) receive FDA 510(k) clearance?

Auris Robotic Endoscopy System (ARES) received FDA 510(k) clearance on 2016-05-26, under 510(k) number K152319.

Who is the listed applicant for Auris Robotic Endoscopy System (ARES)?

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

What is the FDA product code for Auris Robotic Endoscopy System (ARES)?

The FDA product code for Auris Robotic Endoscopy System (ARES) is EOQ.

Ensayos clínicos relacionados

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Otros registros que enlistan a Auris Surgical Robotics, Inc. como solicitante

K173760Monarch Endoscopy Platform (Monarch Platform)

Dispositivos relacionados (Código: EOQ)

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Fuente oficial

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