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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 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.

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. 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.

Other records listing Auris Surgical Robotics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173760Monarch Endoscopy Platform (Monarch Platform)

Related Devices (Code: EOQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm CorporationK260565SmartClip Delivery Catheter (ADR-1715)Elucent MedicalK252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.

Official Source

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

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