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FDA 510(k)

Monarch Endoscopy Platform (Monarch Platform)

K-Number: K173760 · 2018-03-22

ApplicantAuris Surgical Robotics, Inc.
Decision Date2018-03-22
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Monarch Endoscopy Platform (Monarch Platform) is a medical device manufactured by Auris Surgical Robotics, Inc.. It received FDA 510(k) clearance on 2018-03-22 under approval number K173760. 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 Monarch Endoscopy Platform (Monarch Platform)?

Monarch Endoscopy Platform (Monarch Platform) is a medical device that received FDA 510(k) clearance on 2018-03-22. It is manufactured by Auris Surgical Robotics, Inc.. The 510(k) number is K173760.

When was Monarch Endoscopy Platform (Monarch Platform) approved by the FDA?

Monarch Endoscopy Platform (Monarch Platform) received FDA 510(k) clearance on 2018-03-22, under approval number K173760.

What company makes Monarch Endoscopy Platform (Monarch Platform)?

Monarch Endoscopy Platform (Monarch Platform) is manufactured by Auris Surgical Robotics, Inc..

What is the FDA product code for Monarch Endoscopy Platform (Monarch Platform)?

The FDA product code for Monarch Endoscopy Platform (Monarch Platform) is EOQ.

Related Clinical Trials

NCT05231278 Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy COMPLETED

Other Devices by Auris Surgical Robotics, Inc.

K152319Auris Robotic Endoscopy System (ARES)

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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