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FDA 510(k)

Auris Robotic Endoscopy System (ARES)

K-Number: K152319 · 2016-05-26

ApplicantAuris Surgical Robotics, Inc.
Decision Date2016-05-26
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Auris Surgical Robotics, Inc.. The 510(k) number is K152319.

When was Auris Robotic Endoscopy System (ARES) approved by the FDA?

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

What company makes Auris Robotic Endoscopy System (ARES)?

Auris Robotic Endoscopy System (ARES) is manufactured by Auris Surgical Robotics, Inc..

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

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

Related Clinical Trials

NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06690658 Self-Practicing Upper Body Exercises With a Robotic Trainer System RECRUITING NCT07606963 Triton 1.5 Robotic System for Diagnostic Colonoscopy NOT_YET_RECRUITING NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT07524699 A Study About Remote and Local Liver Surgery NOT_YET_RECRUITING NCT07587437 Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Auris Surgical Robotics, Inc.

K173760Monarch Endoscopy Platform (Monarch Platform)

Related Devices (Code: EOQ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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